Home NDC 68001-641 Enoxaparin Sodium
Product NDC 68001-641
11-digit product format 680010641
Labeler code 68001
Product ID 68001-641_3f6241ed-b5ff-9869-e063-6294a90a0156
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Enoxaparin Sodium
Dosage form INJECTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler BluePoint Laboratories
Application ANDA214856
Marketing category ANDA
Marketing start 2025-05-01
Substance ENOXAPARIN SODIUM
Active strength 300 mg/3mL
Pharmacologic classes Heparin, Low-Molecular-Weight [CS], Low Molecular Weight 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 A214856-001 ENOXAPARIN SODIUM ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214856-001 AB
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 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214856-001 ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AB 2022-06-14 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Enoxaparin Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENOXAPARIN SODIUM 300 mg/3mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8NZ41MIK1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 854255 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 68001-641-41 Enoxaparin Sodium 1 in 1 CARTON INJECTION 1 2 68001-641-41 Enoxaparin Sodium 3 mL in 1 VIAL, MULTI-DOSE INJECTION 3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68001-641 ENOXAPARIN SODIUM INJECTION [BLUEPOINT LABORATORIES] 1 Current NDC, 2 package rows 20250502_d978e06e-b758-460b-81d3-69f7a5b89b00.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68001-641-41 68001064141 1 VIAL, MULTI-DOSE in 1 CARTON (68001-641-41) / 3 mL in 1 VIAL, MULTI-DOSE 2025-05-01 No No Current