HEPARIN SODIUM

Product NDC
0404-9873
11-digit product format
004049873
Labeler code
0404
Product ID
0404-9873_9ef7320c-4c2f-4286-82cd-d0430658943e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
heparin sodium injection
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Henry Schein, Inc.
Application
ANDA203851
Marketing category
ANDA
Marketing start
2022-01-11
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0404-9873DDiscontinued by firm2026-08-17
excluded packagepackage0404-98730404-9873-01DDiscontinued by firm2026-08-17

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203851-001HEPARIN SODIUMHEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30
A203851-002HEPARIN SODIUMHEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30
A203851-003HEPARIN SODIUMHEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A203851-001AP
A203851-002AP
A203851-003AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203851-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203851-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203851-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2017-11-301e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203851-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A203851-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A203851-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203851-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203851-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203851-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203851-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203851-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203851-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203851-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203851-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203851-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203851-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203851-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203851-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203851-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203851-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203851-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203851-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203851-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203851-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203851-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203851-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203851-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203851-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203851-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203851-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203851-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203851-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203851-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203851-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203851-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203851-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203851-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203851-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203851-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203851-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203851-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203851-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203851-001AP11e350fbaab3a…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac74f96-3910-44b9-8551-036880fbb1fbProduct name120260108
0a18eae4-4259-42db-86b6-915f66e83b06Product name120250729
2c999b01-2a13-4eff-8eb4-00b87316ef79Product name120231116
05193eb6-d122-ab0b-603b-d9dd92599836Product name220210204
2e5437ef-ff80-c9c2-2f66-5b7c771080beProduct name920180201
ae28a785-50d8-477d-a268-dffdfdd7504bProduct name120150305
0c878822-66ca-456d-c17d-0894b04fa473Product name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9873HEPARIN SODIUM (HEPARIN SODIUM INJECTION) INJECTION [HENRY SCHEIN, INC.]5Legacy NDC20240806_b582b659-e53b-4997-ab8c-f2f784f4a55c.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Heparin SodiumHEPARIN SODIUMMylan Institutional LLC88114716-5759-4bc9-8a85-d28da12962cc2025-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203851
application number: ANDA203851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9873-01004049873011 VIAL, SINGLE-DOSE in 1 BAG (0404-9873-01) > 1 mL in 1 VIAL, SINGLE-DOSE2022-01-110000-00-00NoNoCurrent