FDA.reportPublic FDA data

Heparin Sodium

Product NDC
71839-118
11-digit product format
718390118
Labeler code
71839
Product ID
71839-118_8d799a63-ec08-466c-9bba-cd4a1eebc698
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
BE Pharmaceuticals Inc.
Application
ANDA214839
Marketing category
ANDA
Marketing start
2020-12-29
Substance
HEPARIN SODIUM
Active strength
5000 [USP'U]/.5mL
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 SODIUM5000 [USP'U]/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui1658634

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
71839-118-01Heparin Sodium0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION0.54
71839-118-25Heparin Sodium25 in 1 CARTONINJECTION, SOLUTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71839-118-01ML - Milliliter71839-118612f5f9b-f40e-4624-a550-eaa864d2f90012022-02-07
71839-118-25ML - Milliliter71839-118dc2adfd2-31b6-48b6-8397-dc9add2fe8c012022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71839-118HEPARIN SODIUM INJECTION, SOLUTION [BE PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20241120_6be171fb-c85f-4336-a88d-b4d97bb0fe03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658634heparin sodium, porcine 5000 UNT in 0.5 mL InjectionPSN6be171fb-c85f-4336-a88d-b4d97bb0fe034
16586340.5 ML heparin sodium, porcine 10000 UNT/ML InjectionSCD6be171fb-c85f-4336-a88d-b4d97bb0fe034
1658634heparin sodium, porcine 5000 UNT per 0.5 ML InjectionSY6be171fb-c85f-4336-a88d-b4d97bb0fe034

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71839-118-01718390118010.5 mL in 1 VIAL, SINGLE-DOSE0.5 mlHistorical
71839-118-257183901182525 VIAL, SINGLE-DOSE in 1 CARTON (71839-118-25) / .5 mL in 1 VIAL, SINGLE-DOSE (71839-118-01) 2020-12-290000-00-00NoNoCurrent