FDA.reportPublic FDA data

Heparin Sodium

Product NDC
72603-224
11-digit product format
726030224
Labeler code
72603
Product ID
72603-224_298bc179-9ab8-430f-9733-c33f7ea00d6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
NorthStar RxLLC
Application
ANDA211004
Marketing category
ANDA
Marketing start
2024-04-01
Substance
HEPARIN SODIUM
Active strength
20000 [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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPARIN SODIUM20000 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui1361574

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-224-01Heparin Sodium1 mL in 1 VIAL, MULTI-DOSEINJECTION12
72603-224-25Heparin Sodium25 in 1 CARTONINJECTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-224-01ML - Milliliter72603-224916b85ef-4af9-4dc9-b2c8-157c6752474e12024-06-10
72603-224-25ML - Milliliter72603-224a2af3aaf-da56-45a1-b499-5af3adb1c28c12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-224HEPARIN SODIUM INJECTION [NORTHSTAR RXLLC]1Current NDC, 2 package rows20240402_34b8fe93-ee34-4a35-9af5-5d41705a28e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1361574heparin sodium, porcine 20,000 UNT/ML Injectable SolutionPSN34b8fe93-ee34-4a35-9af5-5d41705a28e92
1361574heparin sodium, porcine 20000 UNT/ML Injectable SolutionSCD34b8fe93-ee34-4a35-9af5-5d41705a28e92
1361574heparin sodium, porcine 20,000 UNT/ML Injectable SolutionSY34b8fe93-ee34-4a35-9af5-5d41705a28e92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-224-01726030224011 mL in 1 VIAL, MULTI-DOSE1 mlHistorical
72603-224-257260302242525 VIAL, MULTI-DOSE in 1 CARTON (72603-224-25) / 1 mL in 1 VIAL, MULTI-DOSE (72603-224-01) 2024-04-01NoNoCurrent