FDA.reportPublic FDA data

Heparin Sodium

Product NDC
55154-2827
11-digit product format
551542827
Labeler code
55154
Product ID
55154-2827_8ff13251-1ffd-4a33-8037-7dc7bfc1f2a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Cardinal Health 107, LLC
Application
ANDA090808
Marketing category
ANDA
Marketing start
2010-07-06
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
Rxcui1361615

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
55154-2827-5Heparin Sodium5 in 1 BAGINJECTION, SOLUTION519
55154-2827-5Heparin Sodium1 mL in 1 VIALINJECTION, SOLUTION119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-2827-5ML - Milliliter55154-2827b287cf35-a203-4fe2-b43a-2206b941a90112019-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HEPARIN SODIUMACTIVE INGREDIENTZZ45AB24CAHEPARIN SODIUM INJECTION [CARDINAL HEALTH]8
HEPARINACTIVE MOIETYT2410KM04AHEPARIN SODIUM INJECTION [CARDINAL HEALTH]8
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHHEPARIN SODIUM INJECTION [CARDINAL HEALTH]8
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBHEPARIN SODIUM INJECTION [CARDINAL HEALTH]8
NitrogenINACTIVE INGREDIENTN762921K75HEPARIN SODIUM INJECTION [CARDINAL HEALTH]8
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XHEPARIN SODIUM INJECTION [CARDINAL HEALTH]8
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IHEPARIN SODIUM INJECTION [CARDINAL HEALTH]8
WaterINACTIVE INGREDIENT059QF0KO0RHEPARIN SODIUM INJECTION [CARDINAL HEALTH]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-2827HEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC]19Current NDC, Legacy NDC, 2 package rows20250507_e0cc5f44-9a67-4274-a48a-d6118e96d391.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionPSNe0cc5f44-9a67-4274-a48a-d6118e96d39119
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionSCDe0cc5f44-9a67-4274-a48a-d6118e96d39119

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-2827-5551542827055 VIAL in 1 BAG (55154-2827-5) / 1 mL in 1 VIAL5 vial2010-07-060000-00-00NoNoCurrent