Home NDC 71839-117 Heparin Sodium
Product NDC 71839-117
11-digit product format 718390117
Labeler code 71839
Product ID 71839-117_4d2cbee1-f461-45a1-bf5f-c8dd4ef8501b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Heparin Sodium
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler BE Pharmaceuticals Inc.
Application ANDA214804
Marketing category ANDA
Marketing start 2020-12-29
Substance HEPARIN SODIUM
Active strength 2000 [USP'U]/2mL
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 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 A214804-001 HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214804-001 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 2026-02-19 14:30 UTC 2026-02 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214804-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2020-12-29 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 2000 [USP'U]/2mL
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 1658647 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 71839-117-01 Heparin Sodium 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 5 71839-117-25 Heparin Sodium 25 in 1 CARTON INJECTION, SOLUTION 25 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71839-117 HEPARIN SODIUM INJECTION, SOLUTION [BE PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 2 package rows 20241120_295ea9c6-d08c-40f0-a908-de0fdac44644.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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71839-117-01 71839011701 2 mL in 1 VIAL, SINGLE-DOSE 2 ml Historical 71839-117-25 71839011725 25 VIAL, SINGLE-DOSE in 1 CARTON (71839-117-25) / 2 mL in 1 VIAL, SINGLE-DOSE (71839-117-01) 2020-12-29 0000-00-00 No No Current