FDA.reportPublic FDA data

Heparin Sodium

Product NDC
71839-117
11-digit product format
718390117
Labeler code
71839
Product ID
71839-117_4d2cbee1-f461-45a1-bf5f-c8dd4ef8501b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
BE Pharmaceuticals Inc.
Application
ANDA214804
Marketing category
ANDA
Marketing start
2020-12-29
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
71839-117-01Heparin Sodium2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION25
71839-117-25Heparin Sodium25 in 1 CARTONINJECTION, SOLUTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71839-117-01ML - Milliliter71839-1170f14f3a3-9b7c-4bb6-ba57-7d3f137c883d12022-02-07
71839-117-25ML - Milliliter71839-11765161ba9-8827-426f-86bc-ed8493a3ec8412022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71839-117HEPARIN SODIUM INJECTION, SOLUTION [BE PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20241120_295ea9c6-d08c-40f0-a908-de0fdac44644.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658647heparin sodium, porcine 2000 UNT in 2 ML InjectionPSN295ea9c6-d08c-40f0-a908-de0fdac446445
16586472 ML heparin sodium, porcine 1000 UNT/ML InjectionSCD295ea9c6-d08c-40f0-a908-de0fdac446445
1658647heparin sodium, porcine 2000 UNT per 2 ML InjectionSY295ea9c6-d08c-40f0-a908-de0fdac446445

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71839-117-01718390117012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
71839-117-257183901172525 VIAL, SINGLE-DOSE in 1 CARTON (71839-117-25) / 2 mL in 1 VIAL, SINGLE-DOSE (71839-117-01) 2020-12-290000-00-00NoNoCurrent