FDA.reportPublic FDA data

Heparin Sodium

Product NDC
71288-406
11-digit product format
712880406
Labeler code
71288
Product ID
71288-406_ab9c214d-f2e3-4043-b2da-b6a56a8b0432
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA212061
Marketing category
ANDA
Marketing start
2020-07-15
Substance
HEPARIN SODIUM
Active strength
5000 [USP'U]/mL
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]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui1798389

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
71288-406-81Heparin Sodium1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION17
71288-406-82Heparin Sodium1 in 1 BLISTER PACKINJECTION, SOLUTION17
71288-406-82Heparin Sodium24 in 1 CARTONINJECTION, SOLUTION247

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-406-81ML - Milliliter71288-4069f01f17b-b862-4089-8a0c-2544501d049412023-06-06
71288-406-82ML - Milliliter71288-406880168e6-a1c4-471a-aa2f-67461bb8028612023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-406HEPARIN SODIUM INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 3 package rows20250323_57f1ec87-8a7d-41da-b8b8-9ecc8601c60f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1798389heparin sodium, porcine 5000 UNT in 1 ML Prefilled SyringePSN57f1ec87-8a7d-41da-b8b8-9ecc8601c60f7
17983891 ML heparin sodium, porcine 5000 UNT/ML Prefilled SyringeSCD57f1ec87-8a7d-41da-b8b8-9ecc8601c60f7
1798389heparin sodium, porcine 5000 UNT per 1 ML Prefilled SyringeSY57f1ec87-8a7d-41da-b8b8-9ecc8601c60f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-406-81712880406811 mL in 1 SYRINGE, GLASS1 mlHistorical
71288-406-827128804068224 BLISTER PACK in 1 CARTON (71288-406-82) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (71288-406-81) 24 blister pack2020-07-150000-00-00NoNoCurrent