Heparin Sodium

Product NDC
72572-255
11-digit product format
725720255
Labeler code
72572
Product ID
72572-255_39ab19f4-c6c0-44b1-a082-6ffee418d184
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Civica, Inc.
Application
NDA017037
Marketing category
NDA
Marketing start
2019-11-15
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
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 · 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
2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1658659Internal RxNorm lookup
1659263Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e362730-5a56-4948-a90f-2cb75fed9e91Available 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
05193eb6-d122-ab0b-603b-d9dd92599836Product name220210204
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
2e5437ef-ff80-c9c2-2f66-5b7c771080beProduct name920180201
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
ae28a785-50d8-477d-a268-dffdfdd7504bProduct name120150305
0c878822-66ca-456d-c17d-0894b04fa473Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72572-255-01Heparin Sodium1 mL in 1 VIALINJECTION13
72572-255-25Heparin Sodium25 in 1 PACKAGEINJECTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-255-01ML - Milliliter72572-2552c1e5f46-0f67-4a11-8910-21f9b63254bc12019-12-10
72572-255-25ML - Milliliter72572-255d3a4d849-0728-49e5-a2ca-36057d0d6e9912019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-255HEPARIN SODIUM INJECTION [CIVICA, INC.]2Current NDC, Legacy NDC, 2 package rows20220820_1e362730-5a56-4948-a90f-2cb75fed9e91.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
Heparin SodiumHEPARIN SODIUMCivica, Inc.1e362730-5a56-4948-a90f-2cb75fed9e912025-07-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 017037
application number: NDA017037
ndc (product): 72572-255

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658659heparin sodium, porcine 1000 UNT in 1 ML InjectionPSN1e362730-5a56-4948-a90f-2cb75fed9e913
1659263heparin sodium, porcine 5000 UNT in 1 ML InjectionPSN1e362730-5a56-4948-a90f-2cb75fed9e913
16586591 ML heparin sodium, porcine 1000 UNT/ML InjectionSCD1e362730-5a56-4948-a90f-2cb75fed9e913
16592631 ML heparin sodium, porcine 5000 UNT/ML InjectionSCD1e362730-5a56-4948-a90f-2cb75fed9e913
1658659heparin sodium, porcine 1000 UNT per 1 ML InjectionSY1e362730-5a56-4948-a90f-2cb75fed9e913
1659263heparin sodium, porcine 5000 UNT per 1 ML InjectionSY1e362730-5a56-4948-a90f-2cb75fed9e913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-255-01725720255011 mL in 1 VIAL1 mlHistorical
72572-255-257257202552525 VIAL in 1 PACKAGE (72572-255-25) / 1 mL in 1 VIAL (72572-255-01) 25 vial2019-11-150000-00-00NoNoCurrent