FDA.reportPublic FDA data

Heparin Sodium

Product NDC
71288-401
11-digit product format
712880401
Labeler code
71288
Product ID
71288-401_154662b0-de60-4dcd-b92d-3401551b04db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA211004
Marketing category
ANDA
Marketing start
2020-02-24
Substance
HEPARIN SODIUM
Active strength
20000 [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 SODIUM20000 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui1361574

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
71288-401-01Heparin Sodium1 mL in 1 VIAL, MULTI-DOSEINJECTION17
71288-401-02Heparin Sodium25 in 1 CARTONINJECTION257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-401-01ML - Milliliter71288-401809e10c0-9b8e-428c-9919-87bb2d70c3b712020-05-08
71288-401-02ML - Milliliter71288-40115b52a1c-57fe-4ecc-b9e3-e49e008621f812020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-401HEPARIN SODIUM INJECTION [MEITHEAL PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 2 package rows20250214_7df6c90c-3b55-4bb6-8a72-6e6a6aca4e7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1361574heparin sodium, porcine 20,000 UNT/ML Injectable SolutionPSN7df6c90c-3b55-4bb6-8a72-6e6a6aca4e7c7
1361574heparin sodium, porcine 20000 UNT/ML Injectable SolutionSCD7df6c90c-3b55-4bb6-8a72-6e6a6aca4e7c7
1361574heparin sodium, porcine 20,000 UNT/ML Injectable SolutionSY7df6c90c-3b55-4bb6-8a72-6e6a6aca4e7c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-401-01712880401011 mL in 1 VIAL, MULTI-DOSE1 mlHistorical
71288-401-027128804010225 VIAL, MULTI-DOSE in 1 CARTON (71288-401-02) / 1 mL in 1 VIAL, MULTI-DOSE (71288-401-01) 2020-02-240000-00-00NoNoCurrent