FDA.reportPublic FDA data

HEPARIN SODIUM

Product NDC
51662-1411
11-digit product format
516621411
Labeler code
51662
Product ID
51662-1411_0fcb6a01-0cd9-a1df-e063-6394a90abb78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HEPARIN SODIUM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA018916
Marketing category
NDA
Marketing start
2019-11-11
Substance
HEPARIN SODIUM
Active strength
10000 [USP'U]/100mL
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 SODIUM10000 [USP'U]/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui1658717

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
51662-1411-1HEPARIN SODIUM250 mL in 1 BAGINJECTION, SOLUTION2505
51662-1411-1HEPARIN SODIUM1 in 1 POUCHINJECTION, SOLUTION15
51662-1411-2HEPARIN SODIUM1 in 1 POUCHINJECTION, SOLUTION15
51662-1411-3HEPARIN SODIUM24 in 1 CASEINJECTION, SOLUTION245

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1411HEPARIN SODIUM INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]5Current NDC, Legacy NDC, 4 package rows20240126_97183edd-fa5c-8ff1-e053-2995a90ae1d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658717heparin sodium, porcine 25,000 UNT in 250 ML InjectionPSN97183edd-fa5c-8ff1-e053-2995a90ae1d55
1658717250 ML heparin sodium, porcine 100 UNT/ML InjectionSCD97183edd-fa5c-8ff1-e053-2995a90ae1d55
1658717heparin sodium, porcine 25,000 UNT per 250 ML InjectionSY97183edd-fa5c-8ff1-e053-2995a90ae1d55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1411-1516621411011 BAG in 1 POUCH (51662-1411-1) > 250 mL in 1 BAG1 bag2019-11-110000-00-00NoNoCurrent
51662-1411-2516621411021 in 1 POUCHHistorical
51662-1411-35166214110324 POUCH in 1 CASE (51662-1411-3) / 1 POUCH in 1 POUCH (51662-1411-2) / 1 BAG in 1 POUCH (51662-1411-1) / 250 mL in 1 BAG24 pouch2023-09-22NoNoHistorical