{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-01", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "spl_product_data_elements": [ "EXTRANEAL icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride ICODEXTRIN ICODEXTRIN SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID, UNSPECIFIED FORM CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION EXTRANEAL icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride ICODEXTRIN ICODEXTRIN SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID, UNSPECIFIED FORM CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION" ], "health_care_provider_letter": [ "Health Care Provider Letter Extraneal DHCP Letter-1 Extraneal DHCP Letter-2 Extraneal DHCP Letter-3 Extraneal DHCP Letter-4 Extraneal DHCP Letter-5 Extraneal DHCP Letter-6 Extraneal DHCP Letter-7 Extraneal DHCP Letter-8 Extraneal DHCP Letter-9" ], "package_label_principal_display_panel": [ "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Lot EXP B4938R 2000 ml Baxter EXTRANEAL Solution for Peritoneal Dialysis Formula 1000 ml mmol/l Icodextrin 75 g Na+ 133 Sodium Chloride 5,4 g Ca++ 1,75 Sodium (S)-lactate 4,5 g Mg++ 0,25 Calcium Chloride 2H 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/l Hydrochloric acid or sodium hydroxide (for pH adjustment) pH 5,0 – 6,0 For intraperitoneal use Not for intravenous use Use as directed by a physician Read the package leaflet before use Keep out of the sight and reach of children Nonpyrogenic Do not store below 4°C Do not use unless solution is clear and container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution UK: Baxter Healthcare Ltd Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom IE and MT: Baxter Holding B.V., Kobaltweg 49, 3542CE, Utrecht, Netherlands PL 00116/0266 PA 2299/017/001 MA 1277/01101 POM Symbol Manufactured by Baxter Healthcare S A IRL-Castlebar CB-35-04-605 EXTRANEAL FPB4938RC 2000 ml x 5 Solution for Peritoneal Dialysis 1000 ml Icodextrin 75 g Sodium Chloride 5,4 g Sodium (S)-lactate 4,5 g Calcium Chloride 2H 2 0 0,257 g Magnesium Chloride 6H 2 0 0,051 g Water for injections to 1000 ml Sodium hydroxide or hydrochloric acid (for pH adjustment) For intraperitoneal use Not for intravenous infusion Keep out of the sight and reach of children UK: Baxter Healthcare Limited Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom IE and MT: Baxter Holding B.V. Kobaltweg 49, 3542CE, Utrecht, Netherlands 88-46-13-193 Lot: EXP Do not store below 4°C Single bag with Luer connector MA 1277/01101 PA 2299/017/001 PL 00116/0266 POM Symbol Barcode (01)55413760441875(17)201200(10)88C88C88B2 EXTRANEAL FPB4938RC 2000 ml x 5 Lot: EXP Lot EXP B4938R 2000 ml Vantive EXTRANEAL Solution for Peritoneal Dialysis Formula 1000 ml mmol/l Icodextrin 75 g Na+ 133 Sodium Chloride 5,4 g Ca++ 1,75 Sodium (S)-lactate 4,5 g Mg++ 0,25 Calcium Chloride 2H 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/l Hydrochloric acid or sodium hydroxide (for pH adjustment) pH 5,0 – 6,0 For intraperitoneal use Not for intravenous use Use as directed by a physician Read the package leaflet before use Keep out of the sight and reach of children Nonpyrogenic Do not store below 4°C Do not use unless solution is clear and container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom PL 58711/0005 POM Symbol CB-35-05-248 EXTRANEAL FPB4938RC 2000 ml x 5 Solution for Peritoneal Dialysis 1000 ml Icodextrin 75 g Sodium Chloride 5,4 g Sodium (S)-lactate 4,5 g Calcium Chloride 2H 2 0 0,257 g Magnesium Chloride 6H 2 0 0,051 g Water for injections to 1000 ml Sodium hydroxide or hydrochloric acid (for pH adjustment) For intraperitoneal use Not for intravenous infusion Keep out of the sight and reach of children Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom 88-46-14-004 Lot: EXP UK Only Do not store below 4°C Single bag with Luer connector PL 58711/0005 POM Symbol Barcode (01)57332414202786(17)201200(10)88C88C88B2 EXTRANEAL FPB4938RC 2000 ml x 5 Lot: EXP Lot EXP B4945R 2500 ml Baxter EXTRANEAL Solution for Peritoneal Dialysis Formula 1000 ml mmol/l Icodextrin 75 g Na+ 133 Sodium Chloride 5,4 g Ca++ 1,75 Sodium (S)-lactate 4,5 g Mg++ 0,25 Calcium Chloride 2H 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/l Hydrochloric acid or sodium hydroxide (for pH adjustment) pH 5,0 – 6,0 For intraperitoneal use Not for intravenous use Use as directed by a physician Read the package leaflet before use Keep out of the sight and reach of children Nonpyrogenic Do not store below 4°C Do not use unless solution is clear and container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution UK: Baxter Healthcare Ltd Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom IE and MT: Baxter Holding B.V., Kobaltweg 49, 3542CE, Utrecht, Netherlands PL 00116/0266 PA 2299/017/001 MA 1277/01101 POM Symbol Manufactured by Baxter Healthcare S A IRL-Castlebar CB-35-04-606 EXTRANEAL FPB4945R 2500 ml x 4 Solution for Peritoneal Dialysis 1000 ml Icodextrin 75 g Sodium Chloride 5,4 g Sodium (S)-lactate 4,5 g Calcium Chloride 2H 2 0 0,257 g Magnesium Chloride 6H 2 0 0,051 g Water for injections to 1000 ml Sodium hydroxide or hydrochloric acid (for pH adjustment) For intraperitoneal use Not for intravenous infusion Keep out of the sight and reach of children UK: Baxter Healthcare Limited Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom IE and MT: Baxter Holding B.V. Kobaltweg 49, 3542CE, Utrecht, Netherlands 88-46-13-194 Lot: EXP Do not store below 4°C Single bag with Luer connector MA 1277/01101 PA 2299/017/001 PL 00116/0266 POM Symbol Barcode (01)50085412574368(17)201200(10)88C88C88B2 EXTRANEAL FPB4945R 2500 ml x 4 Lot: EXP Lot EXP B4945R 2500 ml Vantive EXTRANEAL Solution for Peritoneal Dialysis Formula 1000 ml mmol/l Icodextrin 75 g Na+ 133 Sodium Chloride 5,4 g Ca++ 1,75 Sodium (S)-lactate 4,5 g Mg++ 0,25 Calcium Chloride 2H 2 0 0,257 g Clˉ 96 Magnesium Chloride 6H 2 0 0,051 g C 3 H 5 0 3 ˉ 40 Water for Injections Osmolarity 284 mOsm/l Hydrochloric acid or sodium hydroxide (for pH adjustment) pH 5,0 – 6,0 For intraperitoneal use Not for intravenous use Use as directed by a physician Read the package leaflet before use Keep out of the sight and reach of children Nonpyrogenic Do not store below 4°C Do not use unless solution is clear and container undamaged For single use only Once removed from the overpouch use immediately Discard unused solution Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom PL 58711/0005 POM Symbol CB-35-05-249 EXTRANEAL FPB4945R 2500 ml x 4 Solution for Peritoneal Dialysis 1000 ml Icodextrin 75 g Sodium Chloride 5,4 g Sodium (S)-lactate 4,5 g Calcium Chloride 2H 2 0 0,257 g Magnesium Chloride 6H 2 0 0,051 g Water for injections to 1000 ml Sodium hydroxide or hydrochloric acid (for pH adjustment) For intraperitoneal use Not for intravenous infusion Keep out of the sight and reach of children Vantive Limited Wavertree Technology Park 2 Wavertree Boulevard Liverpool, L7 9PE United Kingdom 88-46-14-005 Lot: EXP UK Only Do not store below 4°C Single bag with Luer connector PL 58711/0005 POM Symbol Barcode (01)57332414203240(17)201200(10)88C88C88B2 EXTRANEAL FPB4945R 2500 ml x 4 Lot: EXP Representative Extraneal Container Label Representative Extraneal Carton Label Vantive Representative Extraneal Container Label Vantive Representative Extraneal Carton Label Representative Extraneal Container Label Representative Extraneal Carton Label Vantive Representative Extraneal Container Label Vantive Representative Extraneal Carton Label" ], "package_label_principal_display_panel_table": [ "
Formula 1000 mlmmol/l
Icodextrin75 gNa+133
Sodium Chloride5,4 gCa++1,75
Sodium (S)-lactate4,5 gMg++0,25
Calcium Chloride 2H 20 0,257 gClˉ96
Magnesium Chloride 6H 20 0,051 gC 3H 50 3ˉ 40
Water for InjectionsOsmolarity284mOsm/l
Hydrochloric acid or sodium hydroxide (for pH adjustment)pH5,0 – 6,0
", "
1000 ml
Icodextrin75 g
Sodium Chloride5,4 g
Sodium (S)-lactate4,5 g
Calcium Chloride 2H 20 0,257 g
Magnesium Chloride 6H 20 0,051 g
Water for injections to 1000 ml
Sodium hydroxide or hydrochloric acid (for pH adjustment)
", "
Formula 1000 mlmmol/l
Icodextrin75 gNa+133
Sodium Chloride5,4 gCa++1,75
Sodium (S)-lactate4,5 gMg++0,25
Calcium Chloride 2H 20 0,257 gClˉ96
Magnesium Chloride 6H 20 0,051 gC 3H 50 3ˉ 40
Water for InjectionsOsmolarity284mOsm/l
Hydrochloric acid or sodium hydroxide (for pH adjustment)pH5,0 – 6,0
", "
1000 ml
Icodextrin75 g
Sodium Chloride5,4 g
Sodium (S)-lactate4,5 g
Calcium Chloride 2H 20 0,257 g
Magnesium Chloride 6H 20 0,051 g
Water for injections to 1000 ml
Sodium hydroxide or hydrochloric acid (for pH adjustment)
", "
Formula 1000 mlmmol/l
Icodextrin75 gNa+133
Sodium Chloride5,4 gCa++1,75
Sodium (S)-lactate4,5 gMg++0,25
Calcium Chloride 2H 20 0,257 gClˉ96
Magnesium Chloride 6H 20 0,051 gC 3H 50 3ˉ 40
Water for InjectionsOsmolarity284mOsm/l
Hydrochloric acid or sodium hydroxide (for pH adjustment)pH5,0 – 6,0
", "
1000 ml
Icodextrin75 g
Sodium Chloride5,4 g
Sodium (S)-lactate4,5 g
Calcium Chloride 2H 20 0,257 g
Magnesium Chloride 6H 20 0,051 g
Water for injections to 1000 ml
Sodium hydroxide or hydrochloric acid (for pH adjustment)
", "
Formula 1000 mlmmol/l
Icodextrin75 gNa+133
Sodium Chloride5,4 gCa++1,75
Sodium (S)-lactate4,5 gMg++0,25
Calcium Chloride 2H 20 0,257 gClˉ96
Magnesium Chloride 6H 20 0,051 gC 3H 50 3ˉ 40
Water for InjectionsOsmolarity284mOsm/l
Hydrochloric acid or sodium hydroxide (for pH adjustment)pH5,0 – 6,0
", "
1000 ml
Icodextrin75 g
Sodium Chloride5,4 g
Sodium (S)-lactate4,5 g
Calcium Chloride 2H 20 0,257 g
Magnesium Chloride 6H 20 0,051 g
Water for injections to 1000 ml
Sodium hydroxide or hydrochloric acid (for pH adjustment)
" ], "set_id": "2b327b13-a0e9-4b2c-9875-4470998e2e30", "id": "348e2829-a0c9-3ee6-e063-6294a90a585d", "effective_time": "20250507", "version": "6", "openfda": { "brand_name": [ "EXTRANEAL" ], "generic_name": [ "ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE" ], "manufacturer_name": [ "Vantive US Healthcare LLC" ], "product_ndc": [ "0941-0681", "0941-0719" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAPERITONEAL" ], "substance_name": [ "CALCIUM CHLORIDE", "ICODEXTRIN", "MAGNESIUM CHLORIDE", "SODIUM CHLORIDE", "SODIUM LACTATE" ], "rxcui": [ "1100742", "1100746" ], "spl_id": [ "348e2829-a0c9-3ee6-e063-6294a90a585d" ], "spl_set_id": [ "2b327b13-a0e9-4b2c-9875-4470998e2e30" ], "package_ndc": [ "0941-0681-02", "0941-0681-08", "0941-0719-01", "0941-0719-05" ], "is_original_packager": [ true ], "unii": [ "M4I0D6VV5M", "451W47IQ8X", "TU7HW0W0QT", "02F3473H9O", "2NX48Z0A9G" ] } } ] }