Home NDC 0941-0679-53 EXTRANEAL
Product NDC 0941-0679
Requested package NDC 0941-0679-53
11-digit product format 009410679
Labeler code 0941
Product ID 0941-0679_8412c95a-1cc2-4ae7-baf9-3dc30d5b93a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Dosage form INJECTION, SOLUTION
Route INTRAPERITONEAL
Labeler Vantive US Healthcare LLC
Application NDA021321
Marketing category NDA
Marketing start 2002-12-20
Substance CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Active strength 25.7; 7.5; 5.08; 535; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021321-001 EXTRANEAL ICODEXTRIN 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021321-001 EXTRANEAL 7.5GM/100ML SOLUTION / INTRAPERITONEAL RLD, RS 2002-12-20 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base EXTRANEAL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ICODEXTRIN 25.7 mg/100mL SODIUM CHLORIDE 7.5 g/100mL SODIUM LACTATE 5.08 mg/100mL CALCIUM CHLORIDE 535 mg/100mL MAGNESIUM CHLORIDE 448 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1100742 Internal RxNorm lookup 1100746 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0941-0679-05 EXTRANEAL 2500 mL in 1 BAG INJECTION, SOLUTION 2500 24 0941-0679-06 EXTRANEAL 2000 mL in 1 BAG INJECTION, SOLUTION 2000 24 0941-0679-52 EXTRANEAL 2000 mL in 1 BAG INJECTION, SOLUTION 2000 24 0941-0679-53 EXTRANEAL 2500 mL in 1 BAG INJECTION, SOLUTION 2500 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CALCIUM CHLORIDE ACTIVE INGREDIENT M4I0D6VV5M EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 12 ICODEXTRIN ACTIVE INGREDIENT 2NX48Z0A9G EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 12 MAGNESIUM CHLORIDE ACTIVE INGREDIENT 02F3473H9O EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 12 SODIUM CHLORIDE ACTIVE INGREDIENT 451W47IQ8X EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 12 SODIUM LACTATE ACTIVE INGREDIENT TU7HW0W0QT EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 12 CHLORIDE ION ACTIVE MOIETY Q32ZN48698 EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 12 ICODEXTRIN ACTIVE MOIETY 2NX48Z0A9G EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 12 LACTIC ACID ACTIVE MOIETY 33X04XA5AT EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 12 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 12 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 12 WATER INACTIVE INGREDIENT 059QF0KO0R EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0941-0679 EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC] 23 Current NDC, Legacy NDC, 4 package rows 20250313_d5b85158-b0d6-4855-9d07-8d1b3ad9ab71.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1100746 Extraneal 0.00232 MEQ/mL / 75 MG/mL / 0.000533 MEQ/mL / 0.0915 MEQ/mL / 0.04 MEQ/mL Injectable Solution PSN d5b85158-b0d6-4855-9d07-8d1b3ad9ab71 24 1100746 calcium chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / magnesium chloride 0.000533 MEQ/ML / sodium chloride 0.0915 MEQ/ML / sodium lactate 0.04 MEQ/ML Injectable Solution [Extraneal] SBD d5b85158-b0d6-4855-9d07-8d1b3ad9ab71 24 1100742 calcium chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / magnesium chloride 0.000533 MEQ/ML / sodium chloride 0.0915 MEQ/ML / sodium lactate 0.04 MEQ/ML Injectable Solution SCD d5b85158-b0d6-4855-9d07-8d1b3ad9ab71 24 1100742 Calcium Chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / Magnesium Chloride 0.000533 MEQ/ML / NaCl 0.0915 MEQ/ML / Sodium Lactate 0.04 MEQ/ML Injectable Solution SY d5b85158-b0d6-4855-9d07-8d1b3ad9ab71 24 1100746 Calcium Chloride 0.00232 MEQ/ML / icodextrin 75 MG/ML / Magnesium Chloride 0.000533 MEQ/ML / NaCl 0.0915 MEQ/ML / Sodium Lactate 0.04 MEQ/ML Injectable Solution [Extraneal] SY d5b85158-b0d6-4855-9d07-8d1b3ad9ab71 24 1100746 Extraneal (calcium chloride 25.7 MG / icodextrin 7.5 GM / magnesium chloride 5.08 MG / sodium chloride 535 MG / sodium lactate 448 MG) per 100 ML Intraperitoneal Solution SY d5b85158-b0d6-4855-9d07-8d1b3ad9ab71 24
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0941-0679-53 00941067953 2500 mL in 1 BAG (0941-0679-53) 2500 ml 2002-12-20 0000-00-00 No No Current