FDA.reportPublic FDA data

Heparin Sodium

Product NDC
71288-405
11-digit product format
712880405
Labeler code
71288
Product ID
71288-405_a72a1c9b-8b89-44ca-962f-879e9832048c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA212060
Marketing category
ANDA
Marketing start
2020-04-02
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
Rxcui2121591

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
71288-405-80Heparin Sodium0.5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.56
71288-405-80Heparin Sodium1 in 1 BLISTER PACKINJECTION, SOLUTION16
71288-405-81Heparin Sodium24 in 1 CARTONINJECTION, SOLUTION246

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-405-80ML - Milliliter71288-4052743d26c-8c88-4df4-b056-fc2a450f0da412023-06-06
71288-405-81ML - Milliliter71288-405947d656e-c1d9-453f-b528-dc5649089cf612023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-405HEPARIN SODIUM INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 3 package rows20250417_ad0f410c-6121-43f9-9844-943472961cb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2121591heparin sodium, porcine 5000 UNT in 0.5 mL Prefilled SyringePSNad0f410c-6121-43f9-9844-943472961cb06
21215910.5 ML heparin sodium, porcine 10000 UNT/ML Prefilled SyringeSCDad0f410c-6121-43f9-9844-943472961cb06
2121591heparin sodium, porcine 5000 UNT per 0.5 ML Prefilled SyringeSYad0f410c-6121-43f9-9844-943472961cb06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-405-80712880405800.5 mL in 1 SYRINGE, GLASS0.5 mlHistorical
71288-405-817128804058124 BLISTER PACK in 1 CARTON (71288-405-81) / 1 SYRINGE, GLASS in 1 BLISTER PACK (71288-405-80) / .5 mL in 1 SYRINGE, GLASS24 blister pack2020-04-020000-00-00NoNoCurrent