FDA.reportPublic FDA data

HEPARIN SODIUM IN SODIUM CHLORIDE

Product NDC
51662-1578
11-digit product format
516621578
Labeler code
51662
Product ID
51662-1578_0ff8e2fb-b791-dd77-e063-6294a90ab4ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HEPARIN SODIUM IN SODIUM CHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA017029
Marketing category
NDA
Marketing start
2021-07-15
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 IN SODIUM CHLORIDE
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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
51662-1578-1HEPARIN SODIUM IN SODIUM CHLORIDE250 mL in 1 BAGINJECTION, SOLUTION2502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1578HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Current NDC, Legacy NDC, 1 package rows20240128_c72b193e-0687-e002-e053-2995a90a7182.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658717heparin sodium, porcine 25,000 UNT in 250 ML InjectionPSNc72b193e-0687-e002-e053-2995a90a71822
1658717250 ML heparin sodium, porcine 100 UNT/ML InjectionSCDc72b193e-0687-e002-e053-2995a90a71822
1658717heparin sodium, porcine 25,000 UNT per 250 ML InjectionSYc72b193e-0687-e002-e053-2995a90a71822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1578-151662157801250 mL in 1 BAG (51662-1578-1) 250 ml2021-07-150000-00-00NoNoCurrent