Home NDC 67457-384 Heparin Sodium
Product NDC 67457-384
11-digit product format 674570384
Labeler code 67457
Product ID 67457-384_0aca9c58-9720-420b-a0fa-3ef6c841f35c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Heparin Sodium
Dosage form INJECTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Mylan Institutional LLC
Application ANDA203851
Marketing category ANDA
Marketing start 2018-03-16
Marketing end 2026-09-30
Substance HEPARIN SODIUM
Active strength 1000 [USP'U]/mL
Pharmacologic classes Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203851-001 HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 A203851-002 HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 A203851-003 HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 126 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 2026-08-18 06:07:40 2026-07 A203851-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203851-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203851-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203851-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203851-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203851-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203851-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203851-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203851-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203851-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203851-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203851-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203851-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203851-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203851-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203851-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203851-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203851-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203851-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203851-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203851-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203851-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203851-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203851-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203851-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203851-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203851-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203851-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203851-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203851-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203851-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203851-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203851-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203851-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203851-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203851-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203851-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203851-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203851-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203851-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2017-11-30 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Heparin Sodium Active Ingredients# Ingredient, Strength table Ingredient Strength HEPARIN SODIUM 1000 [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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1361226 Internal RxNorm lookup 1361615 Internal RxNorm lookup 1362831 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 67457-384-31 Heparin Sodium 30 mL in 1 VIAL, MULTI-DOSE INJECTION 30 10 67457-384-99 Heparin Sodium 25 in 1 CARTON INJECTION 25 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-384 HEPARIN SODIUM INJECTION [MYLAN INSTITUTIONAL LLC] 10 Current NDC, Legacy NDC, 2 package rows 20250501_88114716-5759-4bc9-8a85-d28da12962cc.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 1362831 heparin sodium, porcine 10,000 UNT/ML Injectable Solution PSN 88114716-5759-4bc9-8a85-d28da12962cc 10 1361226 heparin sodium, porcine 1000 UNT/ML Injectable Solution PSN 88114716-5759-4bc9-8a85-d28da12962cc 10 1361615 heparin sodium, porcine 5000 UNT/ML Injectable Solution PSN 88114716-5759-4bc9-8a85-d28da12962cc 10 1361226 heparin sodium, porcine 1000 UNT/ML Injectable Solution SCD 88114716-5759-4bc9-8a85-d28da12962cc 10 1362831 heparin sodium, porcine 10000 UNT/ML Injectable Solution SCD 88114716-5759-4bc9-8a85-d28da12962cc 10 1361615 heparin sodium, porcine 5000 UNT/ML Injectable Solution SCD 88114716-5759-4bc9-8a85-d28da12962cc 10 1362831 heparin sodium, porcine 10,000 UNT/ML Injectable Solution SY 88114716-5759-4bc9-8a85-d28da12962cc 10
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67457-384-31 67457038431 30 mL in 1 VIAL, MULTI-DOSE 30 ml Historical 67457-384-99 67457038499 25 VIAL, MULTI-DOSE in 1 CARTON (67457-384-99) / 30 mL in 1 VIAL, MULTI-DOSE (67457-384-31) 2018-03-16 2026-09-30 No No Current