FDA.reportPublic FDA data

Heparin Sodium

Product NDC
72603-336
11-digit product format
726030336
Labeler code
72603
Product ID
72603-336_aa6e8c00-0911-4b53-9b2c-c3130bccfdcd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
NorthStar RxLLC
Application
ANDA211005
Marketing category
ANDA
Marketing start
2024-04-01
Substance
HEPARIN SODIUM
Active strength
2000 [USP'U]/2mL
Pharmacologic classes
Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Heparin Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPARIN SODIUM2000 [USP'U]/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui1658647

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
72603-336-01Heparin Sodium2 mL in 1 VIAL, SINGLE-DOSEINJECTION22
72603-336-25Heparin Sodium25 in 1 CARTONINJECTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-336-01ML - Milliliter72603-3364da327db-641e-4ae8-beea-31192db077ee12024-06-10
72603-336-25ML - Milliliter72603-3367450120e-4d17-4c1e-8754-480ecbaf103812024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-336HEPARIN SODIUM INJECTION [NORTHSTAR RXLLC]1Current NDC, 2 package rows20240402_41dd053d-49f6-4eb1-b9e7-3508ede82df8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658647heparin sodium, porcine 2000 UNT in 2 ML InjectionPSN41dd053d-49f6-4eb1-b9e7-3508ede82df82
16586472 ML heparin sodium, porcine 1000 UNT/ML InjectionSCD41dd053d-49f6-4eb1-b9e7-3508ede82df82
1658647heparin sodium, porcine 2000 UNT per 2 ML InjectionSY41dd053d-49f6-4eb1-b9e7-3508ede82df82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-336-01726030336012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
72603-336-257260303362525 VIAL, SINGLE-DOSE in 1 CARTON (72603-336-25) / 2 mL in 1 VIAL, SINGLE-DOSE (72603-336-01) 2024-04-01NoNoHistorical