FDA.reportPublic FDA data

HEPARIN SODIUM IN SODIUM CHLORIDE

Product NDC
51662-1578
Requested package NDC
51662-1578-1
11-digit product format
516621578
Labeler code
51662
Product ID
51662-1578_0ff8e2fb-b791-dd77-e063-6294a90ab4ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HEPARIN SODIUM IN SODIUM CHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA017029
Marketing category
NDA
Marketing start
2021-07-15
Substance
HEPARIN SODIUM
Active strength
10000 [USP'U]/100mL
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 1.

Orange Book products#

Current product rows page 1 of 1 · 16 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017029-001HEPARIN SODIUMHEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N017029-002HEPARIN SODIUMHEPARIN SODIUM5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONApproved before 1982
N017029-003HEPARIN SODIUMHEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N017029-004HEPARIN SODIUMHEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N017029-010HEPARIN SODIUM PRESERVATIVE FREEHEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS1986-04-28
N017029-013HEPARIN SODIUM IN PLASTIC CONTAINERHEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-05
N017029-014HEPARIN SODIUM IN PLASTIC CONTAINERHEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-05
N017029-015HEPARIN SODIUM IN PLASTIC CONTAINERHEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-05
N017029-016HEPARIN SODIUM IN PLASTIC CONTAINERHEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-05
N017029-019HEPARIN SODIUM PRESERVATIVE FREEHEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS2010-11-22
N017029-020HEPARIN SODIUMHEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-03-31
N017029-021HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%HEPARIN SODIUM40 UNITS/MLINJECTABLE / INJECTIONRLD2017-08-24
N017029-022HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%HEPARIN SODIUM50 UNITS/MLINJECTABLE / INJECTIONRLD, RS2017-08-24
N017029-023HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%HEPARIN SODIUM100 UNITS/MLINJECTABLE / INJECTIONRLD, RS2017-08-24
N017029-024HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%HEPARIN SODIUM50 UNITS/MLINJECTABLE / INJECTIONRLD, RS2017-08-24
N017029-025HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%HEPARIN SODIUM100 UNITS/MLINJECTABLE / INJECTIONRLD, RS2017-08-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 9 matching rows.

Application-product, TE code table
Application-productTE code
N017029-001AP
N017029-003AP
N017029-004AP
N017029-010AP
N017029-013AP
N017029-014AP
N017029-015AP
N017029-016AP
N017029-019AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N017029-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N017029-002HEPARIN SODIUM5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONApproved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N017029-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N017029-004HEPARIN SODIUM20,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N017029-010HEPARIN SODIUM PRESERVATIVE FREE1,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS1986-04-28a50c72e98297…
2026-08-01 22:54:322026-06N017029-013HEPARIN SODIUM IN PLASTIC CONTAINER1,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-05a50c72e98297…
2026-08-01 22:54:322026-06N017029-014HEPARIN SODIUM IN PLASTIC CONTAINER5,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-05a50c72e98297…
2026-08-01 22:54:322026-06N017029-015HEPARIN SODIUM IN PLASTIC CONTAINER10,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-05a50c72e98297…
2026-08-01 22:54:322026-06N017029-016HEPARIN SODIUM IN PLASTIC CONTAINER20,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-05a50c72e98297…
2026-08-01 22:54:322026-06N017029-019HEPARIN SODIUM PRESERVATIVE FREE10,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS2010-11-22a50c72e98297…
2026-08-01 22:54:322026-06N017029-020HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-03-31a50c72e98297…
2026-08-01 22:54:322026-06N017029-021HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%40 UNITS/MLINJECTABLE / INJECTIONRLD2017-08-24a50c72e98297…
2026-08-01 22:54:322026-06N017029-022HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%50 UNITS/MLINJECTABLE / INJECTIONRLD, RS2017-08-24a50c72e98297…
2026-08-01 22:54:322026-06N017029-023HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%100 UNITS/MLINJECTABLE / INJECTIONRLD, RS2017-08-24a50c72e98297…
2026-08-01 22:54:322026-06N017029-024HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%50 UNITS/MLINJECTABLE / INJECTIONRLD, RS2017-08-24a50c72e98297…
2026-08-01 22:54:322026-06N017029-025HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%100 UNITS/MLINJECTABLE / INJECTIONRLD, RS2017-08-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N017029-001AP1a50c72e98297…
2026-08-01 22:54:322026-06N017029-003AP1a50c72e98297…
2026-08-01 22:54:322026-06N017029-004AP1a50c72e98297…
2026-08-01 22:54:322026-06N017029-010AP1a50c72e98297…
2026-08-01 22:54:322026-06N017029-013AP1a50c72e98297…
2026-08-01 22:54:322026-06N017029-014AP1a50c72e98297…
2026-08-01 22:54:322026-06N017029-015AP1a50c72e98297…
2026-08-01 22:54:322026-06N017029-016AP1a50c72e98297…
2026-08-01 22:54:322026-06N017029-019AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Heparin SodiumHEPARIN SODIUMCardinal Health 107, LLCf67eea4e-80ff-48da-8b04-8addc5cd31d12026-05-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 017029
application number: NDA017029
Heparin SodiumHEPARIN SODIUMFresenius Kabi USA, LLC2a173253-dfdc-4d9d-8dee-b9c13e6fa9f52026-04-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 017029
application number: NDA017029
Heparin SodiumHEPARIN SODIUMFresenius Kabi USA, LLCd55b4a63-0c04-4874-b74f-9e9b9e8b008c2025-11-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 017029
application number: NDA017029
Heparin SodiumHEPARIN SODIUMFresenius Kabi USA, LLCed937dd2-8fab-4875-a1e8-627b71ccb7fb2025-11-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 017029
application number: NDA017029
Heparin SodiumHEPARIN SODIUMHenry Schein, Inc.3a998729-c912-4e21-8e49-d1e72ba6fe9e2025-10-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 017029
application number: NDA017029
Heparin SodiumHEPARIN SODIUMCardinal Health 107, LLC239b4816-6a55-451b-bf40-e611be07d12f2025-10-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 017029
application number: NDA017029
Heparin SodiumHEPARIN SODIUMFresenius Kabi USA, LLC9207cef5-4cec-41e7-a351-29ba726feb442025-08-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 017029
application number: NDA017029
Heparin SodiumHEPARIN SODIUMPhlow Corporationcece935c-1c0a-4949-b023-d6df3d53fbfa2024-05-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 017029
application number: NDA017029
Heparin SodiumHEPARIN SODIUMFresenius Kabi USA, LLCcb1c1e7a-c9ca-4a07-8833-e45ce436d2872024-04-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 017029
application number: NDA017029
HEPARIN SODIUMHEPARIN SODIUMHF Acquisition Co LLC, DBA HealthFirst971505d4-f78c-6f5d-e053-2995a90a00e02024-01-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 017029
application number: NDA017029
HEPARIN SODIUM IN SODIUM CHLORIDEHEPARIN SODIUM IN SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstc72b193e-0687-e002-e053-2995a90a71822024-01-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 017029
application number: NDA017029
ndc (package): 51662-1578-1
ndc (product): 51662-1578
ndc11 (package): 51662157801
Heparin SodiumHEPARIN SODIUMFresenius Kabi USA, LLCa120bdfd-21e1-4024-82a7-13cfeed290c12024-01-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 017029
application number: NDA017029
Heparin SodiumHEPARIN SODIUMFresenius Kabi USA, LLC3facd525-b9ad-46d0-b63e-f13a5f6d591d2021-09-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 017029
application number: NDA017029

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPARIN SODIUM10000 [USP'U]/100mL

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
1658717Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c72b193e-0687-e002-e053-2995a90a7182Available 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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
51662-1578-1HEPARIN SODIUM IN SODIUM CHLORIDE250 mL in 1 BAGINJECTION, SOLUTION2502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1578HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Current NDC, Legacy NDC, 1 package rows20240128_c72b193e-0687-e002-e053-2995a90a7182.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658717heparin sodium, porcine 25,000 UNT in 250 ML InjectionPSNc72b193e-0687-e002-e053-2995a90a71822
1658717250 ML heparin sodium, porcine 100 UNT/ML InjectionSCDc72b193e-0687-e002-e053-2995a90a71822
1658717heparin sodium, porcine 25,000 UNT per 250 ML InjectionSYc72b193e-0687-e002-e053-2995a90a71822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1578-151662157801250 mL in 1 BAG (51662-1578-1) 250 ml2021-07-150000-00-00NoNoCurrent