FDA.reportPublic FDA data

Heparin Sodium

Product NDC
55154-9585
11-digit product format
551549585
Labeler code
55154
Product ID
55154-9585_cf6de552-021d-4221-b3de-f020f77cd959
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HEPARIN SODIUM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Cardinal Health 107, LLC
Application
NDA017029
Marketing category
NDA
Marketing start
2020-03-25
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Heparin Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPARIN SODIUM5000 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui1361615, 1658634

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
55154-9585-5Heparin Sodium1 mL in 1 VIALINJECTION, SOLUTION15
55154-9585-5Heparin Sodium5 in 1 BAGINJECTION, SOLUTION55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-9585HEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC]3Current NDC, Legacy NDC, 2 package rows20240229_f67eea4e-80ff-48da-8b04-8addc5cd31d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658634heparin sodium, porcine 5000 UNT in 0.5 mL InjectionPSNf67eea4e-80ff-48da-8b04-8addc5cd31d15
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionPSNf67eea4e-80ff-48da-8b04-8addc5cd31d15
16586340.5 ML heparin sodium, porcine 10000 UNT/ML InjectionSCDf67eea4e-80ff-48da-8b04-8addc5cd31d15
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionSCDf67eea4e-80ff-48da-8b04-8addc5cd31d15
1658634heparin sodium, porcine 5000 UNT per 0.5 ML InjectionSYf67eea4e-80ff-48da-8b04-8addc5cd31d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-9585-5551549585055 VIAL in 1 BAG (55154-9585-5) / 1 mL in 1 VIAL5 vial2020-03-250000-00-00NoNoCurrent