FDA.reportPublic FDA data

Heparin Sodium

Product NDC
0641-0410
11-digit product format
006410410
Labeler code
0641
Product ID
0641-0410_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
10000 [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

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui1361226, 1361615, 1362831, 1659263, 1798389, 2121591

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
0641-0410-12Heparin Sodium25 in 1 PACKAGEINJECTION2517
0641-0410-37Heparin Sodium1 mL in 1 VIALINJECTION117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-0410-12ML - Milliliter0641-041056dd3f0d-f2bc-4b20-ba81-e35b5df0063d12012-07-24
0641-0410-37ML - Milliliter0641-04108e39a8a2-2564-493c-99c9-07db122d25b512013-10-17

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
0641-0410HEPARIN SODIUM INJECTION HEPARIN SODIUM INJECTION [HIKMA PHARMACEUTICALS USA INC.]16Current NDC, Legacy NDC, 2 package rows20240411_7014808d-cec9-4b2c-8eb5-940493e356ab.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-0410-120064104101225 VIAL in 1 PACKAGE (0641-0410-12) / 1 mL in 1 VIAL (0641-0410-37) 25 vial1972-03-220000-00-00NoNoCurrent
0641-0410-37006410410371 mL in 1 VIAL1 mlHistorical