Home NDC 67457-952-04 Heparin Sodium
Product NDC 67457-952
Requested package NDC 67457-952-04
11-digit product format 674570952
Labeler code 67457
Product ID 67457-952_c1c9c265-453e-4464-8b8f-682b3fb42f0a
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 2019-02-21
Marketing end 2021-09-30
Substance HEPARIN SODIUM
Active strength 10000 [USP'U]/mL
Pharmacologic classes Anti-coagulant [EPC],Heparin [CS],Unfractionated Heparin [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67457-952-04 67457095204 25 VIAL, MULTI-DOSE in 1 CARTON (67457-952-04) > 4 mL in 1 VIAL, MULTI-DOSE (67457-952-00) 2019-02-21 2021-09-30 No No Current