Home NDC 71288-401 Heparin Sodium
Product NDC 71288-401
11-digit product format 712880401
Labeler code 71288
Product ID 71288-401_154662b0-de60-4dcd-b92d-3401551b04db
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Heparin Sodium
Dosage form INJECTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA211004
Marketing category ANDA
Marketing start 2020-02-24
Substance HEPARIN SODIUM
Active strength 20000 [USP'U]/mL
Pharmacologic classes Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
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 43 .
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 A211004-001 HEPARIN SODIUM HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211004-001 AP
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.
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 2026-09-14 22:38:34 2026-08 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211004-001 HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE / INJECTION AP 2020-02-24 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Heparin Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HEPARIN SODIUM 20000 [USP'U]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ZZ45AB24CA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1361574 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 71288-401-01 Heparin Sodium 1 mL in 1 VIAL, MULTI-DOSE INJECTION 1 7 71288-401-02 Heparin Sodium 25 in 1 CARTON INJECTION 25 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-401 HEPARIN SODIUM INJECTION [MEITHEAL PHARMACEUTICALS INC.] 7 Current NDC, Legacy NDC, 2 package rows 20250214_7df6c90c-3b55-4bb6-8a72-6e6a6aca4e7c.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71288-401-01 71288040101 1 mL in 1 VIAL, MULTI-DOSE 1 ml Historical 71288-401-02 71288040102 25 VIAL, MULTI-DOSE in 1 CARTON (71288-401-02) / 1 mL in 1 VIAL, MULTI-DOSE (71288-401-01) 2020-02-24 0000-00-00 No No Current