FDA.reportPublic FDA data

Heparin Sodium

Product NDC
71288-400
11-digit product format
712880400
Labeler code
71288
Product ID
71288-400_dabdb746-a0fb-4208-ab3c-32e638396713
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA211005
Marketing category
ANDA
Marketing start
2019-06-15
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
71288-400-02Heparin Sodium2 mL in 1 VIAL, SINGLE-DOSEINJECTION25
71288-400-03Heparin Sodium25 in 1 CARTONINJECTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-400-02ML - Milliliter71288-40057047036-b410-49f2-a28b-f45148e6080012019-08-06
71288-400-03ML - Milliliter71288-4008d3e49f9-24aa-4eab-b375-03c8ffe3a09b12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-400HEPARIN SODIUM INJECTION [MEITHEAL PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20250330_83a59e7d-63e9-4eb8-87f0-52039d6893a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658647heparin sodium, porcine 2000 UNT in 2 ML InjectionPSN83a59e7d-63e9-4eb8-87f0-52039d6893a55
16586472 ML heparin sodium, porcine 1000 UNT/ML InjectionSCD83a59e7d-63e9-4eb8-87f0-52039d6893a55
1658647heparin sodium, porcine 2000 UNT per 2 ML InjectionSY83a59e7d-63e9-4eb8-87f0-52039d6893a55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-400-02712880400022 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
71288-400-037128804000325 VIAL, SINGLE-DOSE in 1 CARTON (71288-400-03) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-400-02) 2019-06-150000-00-00NoNoCurrent