Heparin Sodium

Product NDC
0641-0400
11-digit product format
006410400
Labeler code
0641
Product ID
0641-0400_3d3993a7-2f8d-4124-9065-1759b0d98aaf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA017037
Marketing category
NDA
Marketing start
1972-03-22
Substance
HEPARIN SODIUM
Active strength
5000 [USP'U]/mL
Pharmacologic classes
Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017037-001HEPARIN SODIUMHEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N017037-002HEPARIN SODIUMHEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N017037-003HEPARIN SODIUMHEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N017037-013HEPARIN SODIUMHEPARIN SODIUM5,000 UNITS/0.5MLINJECTABLE / INJECTION1986-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N017037-001AP
N017037-002AP
N017037-003AP

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N017037-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N017037-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N017037-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N017037-013HEPARIN SODIUM5,000 UNITS/0.5MLINJECTABLE / INJECTION1986-04-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017037-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017037-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017037-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017037-013HEPARIN SODIUM5,000 UNITS/0.5MLINJECTABLE / INJECTION1986-04-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017037-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017037-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017037-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017037-013HEPARIN SODIUM5,000 UNITS/0.5MLINJECTABLE / INJECTION1986-04-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N017037-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017037-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017037-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017037-013HEPARIN SODIUM5,000 UNITS/0.5MLINJECTABLE / INJECTION1986-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017037-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017037-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017037-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017037-013HEPARIN SODIUM5,000 UNITS/0.5MLINJECTABLE / INJECTION1986-04-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017037-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017037-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017037-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017037-013HEPARIN SODIUM5,000 UNITS/0.5MLINJECTABLE / INJECTION1986-04-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017037-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017037-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017037-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017037-013HEPARIN SODIUM5,000 UNITS/0.5MLINJECTABLE / INJECTIONAP1986-04-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017037-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017037-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017037-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017037-013HEPARIN SODIUM5,000 UNITS/0.5MLINJECTABLE / INJECTIONAP1986-04-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017037-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017037-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017037-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017037-013HEPARIN SODIUM5,000 UNITS/0.5MLINJECTABLE / INJECTIONAP1986-04-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017037-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017037-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017037-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017037-013HEPARIN SODIUM5,000 UNITS/0.5MLINJECTABLE / INJECTIONAP1986-04-07d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 138 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N017037-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N017037-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N017037-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017037-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017037-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017037-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017037-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017037-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017037-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017037-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017037-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017037-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017037-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017037-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017037-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017037-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017037-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017037-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017037-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017037-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017037-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017037-013AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017037-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017037-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017037-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017037-013AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017037-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017037-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017037-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017037-013AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017037-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017037-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017037-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017037-013AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017037-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N017037-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N017037-003AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N017037-013AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017037-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017037-002AP179d66fd596c7…

Additional Listing Data#

Finished product
Yes
Brand name base
Heparin Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPARIN SODIUM5000 [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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1361226Internal RxNorm lookup
1361615Internal RxNorm lookup
1362831Internal RxNorm lookup
1659263Internal RxNorm lookup
1798389Internal RxNorm lookup
2121591Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7014808d-cec9-4b2c-8eb5-940493e356abAvailable 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
0641-0400-12Heparin Sodium25 in 1 PACKAGEINJECTION2517
0641-0400-37Heparin Sodium1 mL in 1 VIALINJECTION117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-0400-12ML - Milliliter0641-0400db935b1c-8a0b-4f2a-b4ed-60ab2cb7ec9e12012-07-24
0641-0400-37ML - Milliliter0641-040091bfa7c2-7247-4dea-a0e8-54b1de6920ae12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HEPARIN SODIUMACTIVE INGREDIENTZZ45AB24CAHEPARIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
HEPARINACTIVE MOIETYT2410KM04AHEPARIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHHEPARIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XHEPARIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-0400HEPARIN SODIUM INJECTION HEPARIN SODIUM INJECTION [HIKMA PHARMACEUTICALS USA INC.]16Current NDC, Legacy NDC, 2 package rows20240411_7014808d-cec9-4b2c-8eb5-940493e356ab.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Heparin SodiumHEPARIN SODIUMCardinal Health 107, LLC62cfd1bb-894f-4429-b362-1e40981dccc62026-06-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 017037
application number: NDA017037
Heparin SodiumHEPARIN SODIUMREMEDYREPACK INC.a5fab0b1-c472-489c-ba87-2f8e533561732026-01-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 017037
application number: NDA017037
Heparin SodiumHEPARIN SODIUMHikma Pharmaceuticals USA Inc.7014808d-cec9-4b2c-8eb5-940493e356ab2025-08-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 017037
application number: NDA017037
ndc (product): 0641-0400
Heparin SodiumHEPARIN SODIUMCivica, Inc.1e362730-5a56-4948-a90f-2cb75fed9e912025-07-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 017037
application number: NDA017037

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionPSN7014808d-cec9-4b2c-8eb5-940493e356ab17
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSN7014808d-cec9-4b2c-8eb5-940493e356ab17
2121591heparin sodium, porcine 5000 UNT in 0.5 mL Prefilled SyringePSN7014808d-cec9-4b2c-8eb5-940493e356ab17
1659263heparin sodium, porcine 5000 UNT in 1 ML InjectionPSN7014808d-cec9-4b2c-8eb5-940493e356ab17
1798389heparin sodium, porcine 5000 UNT in 1 ML Prefilled SyringePSN7014808d-cec9-4b2c-8eb5-940493e356ab17
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionPSN7014808d-cec9-4b2c-8eb5-940493e356ab17
21215910.5 ML heparin sodium, porcine 10000 UNT/ML Prefilled SyringeSCD7014808d-cec9-4b2c-8eb5-940493e356ab17
16592631 ML heparin sodium, porcine 5000 UNT/ML InjectionSCD7014808d-cec9-4b2c-8eb5-940493e356ab17
17983891 ML heparin sodium, porcine 5000 UNT/ML Prefilled SyringeSCD7014808d-cec9-4b2c-8eb5-940493e356ab17
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCD7014808d-cec9-4b2c-8eb5-940493e356ab17
1362831heparin sodium, porcine 10000 UNT/ML Injectable SolutionSCD7014808d-cec9-4b2c-8eb5-940493e356ab17
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionSCD7014808d-cec9-4b2c-8eb5-940493e356ab17
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionSY7014808d-cec9-4b2c-8eb5-940493e356ab17
2121591heparin sodium, porcine 5000 UNT per 0.5 ML Prefilled SyringeSY7014808d-cec9-4b2c-8eb5-940493e356ab17
1659263heparin sodium, porcine 5000 UNT per 1 ML InjectionSY7014808d-cec9-4b2c-8eb5-940493e356ab17
1798389heparin sodium, porcine 5000 UNT per 1 ML Prefilled SyringeSY7014808d-cec9-4b2c-8eb5-940493e356ab17
1659263heparin sodium, porcine 5000 UNT in 1 ML InjectionPSN62cfd1bb-894f-4429-b362-1e40981dccc67
16592631 ML heparin sodium, porcine 5000 UNT/ML InjectionSCD62cfd1bb-894f-4429-b362-1e40981dccc67
1659263heparin sodium, porcine 5000 UNT per 1 ML InjectionSY62cfd1bb-894f-4429-b362-1e40981dccc67
1659263heparin sodium, porcine 5000 UNT in 1 ML InjectionPSNa5fab0b1-c472-489c-ba87-2f8e533561731
16592631 ML heparin sodium, porcine 5000 UNT/ML InjectionSCDa5fab0b1-c472-489c-ba87-2f8e533561731
1659263heparin sodium, porcine 5000 UNT per 1 ML InjectionSYa5fab0b1-c472-489c-ba87-2f8e533561731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-0400-120064104001225 VIAL in 1 PACKAGE (0641-0400-12) / 1 mL in 1 VIAL (0641-0400-37) 25 vial1972-03-220000-00-00NoNoCurrent
0641-0400-37006410400371 mL in 1 VIAL1 mlHistorical