FDA.reportPublic FDA data

Heparin Sodium

Product NDC
71288-403
11-digit product format
712880403
Labeler code
71288
Product ID
71288-403_505f018d-608d-4dd4-b7b9-640b25b0fc44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA211007
Marketing category
ANDA
Marketing start
2019-06-15
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
Rxcui1361226, 1361615, 1362831, 1658637, 1658659, 1659263

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
05193eb6-d122-ab0b-603b-d9dd92599836Product name220210204
2e5437ef-ff80-c9c2-2f66-5b7c771080beProduct name920180201
ae28a785-50d8-477d-a268-dffdfdd7504bProduct name120150305
0c878822-66ca-456d-c17d-0894b04fa473Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-403-01Heparin Sodium1 mL in 1 VIAL, SINGLE-DOSEINJECTION112
71288-403-02Heparin Sodium25 in 1 CARTONINJECTION2512
71288-403-10Heparin Sodium10 mL in 1 VIAL, MULTI-DOSEINJECTION1012
71288-403-11Heparin Sodium25 in 1 CARTONINJECTION2512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-403-01ML - Milliliter71288-403185aa58d-bd89-4782-b75f-29c39828af8e12019-08-06
71288-403-02ML - Milliliter71288-4039ac7ea1c-d95c-4f16-8a7c-6bde879b131912019-08-06
71288-403-10ML - Milliliter71288-40375a9e4a3-80a8-4a1a-8d92-abc99b1979f112019-08-06
71288-403-11ML - Milliliter71288-403475ce952-da10-43fe-abf4-7e2c38b132cd12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-403HEPARIN SODIUM INJECTION [MEITHEAL PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 4 package rows20250205_02fb700d-a28c-4d45-b78d-382dc0d5986c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658637heparin sodium, porcine 10,000 UNT in 1 ML InjectionPSN02fb700d-a28c-4d45-b78d-382dc0d5986c12
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionPSN02fb700d-a28c-4d45-b78d-382dc0d5986c12
1658659heparin sodium, porcine 1000 UNT in 1 ML InjectionPSN02fb700d-a28c-4d45-b78d-382dc0d5986c12
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSN02fb700d-a28c-4d45-b78d-382dc0d5986c12
1659263heparin sodium, porcine 5000 UNT in 1 ML InjectionPSN02fb700d-a28c-4d45-b78d-382dc0d5986c12
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionPSN02fb700d-a28c-4d45-b78d-382dc0d5986c12
16586591 ML heparin sodium, porcine 1000 UNT/ML InjectionSCD02fb700d-a28c-4d45-b78d-382dc0d5986c12
16586371 ML heparin sodium, porcine 10000 UNT/ML InjectionSCD02fb700d-a28c-4d45-b78d-382dc0d5986c12
16592631 ML heparin sodium, porcine 5000 UNT/ML InjectionSCD02fb700d-a28c-4d45-b78d-382dc0d5986c12
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCD02fb700d-a28c-4d45-b78d-382dc0d5986c12
1362831heparin sodium, porcine 10000 UNT/ML Injectable SolutionSCD02fb700d-a28c-4d45-b78d-382dc0d5986c12
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionSCD02fb700d-a28c-4d45-b78d-382dc0d5986c12
1658637heparin sodium, porcine 10,000 UNT per 1 ML InjectionSY02fb700d-a28c-4d45-b78d-382dc0d5986c12
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionSY02fb700d-a28c-4d45-b78d-382dc0d5986c12
1658659heparin sodium, porcine 1000 UNT per 1 ML InjectionSY02fb700d-a28c-4d45-b78d-382dc0d5986c12
1659263heparin sodium, porcine 5000 UNT per 1 ML InjectionSY02fb700d-a28c-4d45-b78d-382dc0d5986c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-403-01712880403011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
71288-403-027128804030225 VIAL, SINGLE-DOSE in 1 CARTON (71288-403-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-403-01) 2019-06-150000-00-00NoNoCurrent
71288-403-107128804031010 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
71288-403-117128804031125 VIAL, MULTI-DOSE in 1 CARTON (71288-403-11) / 10 mL in 1 VIAL, MULTI-DOSE (71288-403-10) 2019-06-150000-00-00NoNoCurrent