HEPARIN SODIUM

Product NDC
51662-1434
11-digit product format
516621434
Labeler code
51662
Product ID
51662-1434_2b3948f4-fde7-5321-e063-6394a90ad70c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HEPARIN SODIUM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA203198
Marketing category
ANDA
Marketing start
2020-01-10
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
2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203198-001HEPARIN SODIUMHEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12
A203198-002HEPARIN SODIUMHEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203198-001AP
A203198-002AP

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12caaa826d4ba7…
2026-08-18 06:07:402026-07A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203198-001HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203198-002HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203198-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A203198-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203198-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203198-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203198-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203198-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203198-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203198-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203198-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203198-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203198-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203198-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203198-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203198-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203198-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203198-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203198-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203198-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203198-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203198-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203198-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203198-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203198-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203198-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203198-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203198-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203198-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203198-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203198-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203198-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203198-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203198-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203198-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203198-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203198-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203198-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203198-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203198-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203198-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203198-002AP1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
HEPARIN SODIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPARIN SODIUM10000 [USP'U]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ZZ45AB24CAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1362831Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9bd0f982-30f4-4e38-e053-2a95a90a3e15Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1434-1HEPARIN SODIUM1 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1434HEPARIN SODIUM INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]3Current NDC, Legacy NDC, 1 package rows20250110_9bd0f982-30f4-4e38-e053-2a95a90a3e15.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Heparin SodiumHEPARIN SODIUMHepalink USA Inc.c4c6bc1f-e0c7-fd0d-e053-2995a90abdef2025-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203198
application number: ANDA203198
Heparin SodiumHEPARIN SODIUMNorthstar Rx LLC2edf6d35-5cf3-b7ff-e063-6394a90a4f332025-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203198
application number: ANDA203198
Heparin SodiumHEPARIN SODIUMSandoz Inc.1c634e53-44d6-cdcd-e063-6294a90a92e92025-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203198
application number: ANDA203198
Heparin SodiumHEPARIN SODIUMMcKesson Corporation dba SKY Packaging7f05762a-7527-4796-b21e-68277aec379e2025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203198
application number: ANDA203198
HEPARIN SODIUMHEPARIN SODIUMHF Acquisition Co LLC, DBA HealthFirst9bd0f982-30f4-4e38-e053-2a95a90a3e152025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203198
application number: ANDA203198
ndc (product): 51662-1434

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionPSN9bd0f982-30f4-4e38-e053-2a95a90a3e153
1362831heparin sodium, porcine 10000 UNT/ML Injectable SolutionSCD9bd0f982-30f4-4e38-e053-2a95a90a3e153
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionSY9bd0f982-30f4-4e38-e053-2a95a90a3e153

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1434-1516621434011 mL in 1 VIAL, MULTI-DOSE (51662-1434-1) 1 ml2020-01-100000-00-00NoNoCurrent