FDA.reportPublic FDA data

Heparin Sodium

Product NDC
25021-404
11-digit product format
250210404
Labeler code
25021
Product ID
25021-404_bb6d321d-a569-4736-88a0-c979074d71ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
heparin sodium
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA090809
Marketing category
ANDA
Marketing start
2010-07-06
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPARIN SODIUM20000 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA

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
25021-404-01Heparin Sodium1 mL in 1 VIALINJECTION118
25021-404-01Heparin Sodium25 in 1 CARTONINJECTION2518

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-404-01ML - Milliliter25021-404d54afc7e-fe83-4330-a38e-2f3e40a1f7b412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
heparin sodiumACTIVE INGREDIENTZZ45AB24CAHEPARIN SODIUM INJECTION [SAGENT PHARMACEUTICALS]15
heparinACTIVE MOIETYT2410KM04AHEPARIN SODIUM INJECTION [SAGENT PHARMACEUTICALS]15
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHHEPARIN SODIUM INJECTION [SAGENT PHARMACEUTICALS]15
hydrochloric acidINACTIVE INGREDIENTQTT17582CBHEPARIN SODIUM INJECTION [SAGENT PHARMACEUTICALS]15
nitrogenINACTIVE INGREDIENTN762921K75HEPARIN SODIUM INJECTION [SAGENT PHARMACEUTICALS]15
sodium hydroxideINACTIVE INGREDIENT55X04QC32IHEPARIN SODIUM INJECTION [SAGENT PHARMACEUTICALS]15
waterINACTIVE INGREDIENT059QF0KO0RHEPARIN SODIUM INJECTION [SAGENT PHARMACEUTICALS]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-404HEPARIN SODIUM INJECTION [SAGENT PHARMACEUTICALS]18Current NDC, Legacy NDC, 2 package rows20220409_feec2820-502f-4a97-84c9-f173729c51d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1361574heparin sodium, porcine 20,000 UNT/ML Injectable SolutionPSNfeec2820-502f-4a97-84c9-f173729c51d318
1361574heparin sodium, porcine 20000 UNT/ML Injectable SolutionSCDfeec2820-502f-4a97-84c9-f173729c51d318
1361574heparin sodium, porcine 20,000 UNT/ML Injectable SolutionSYfeec2820-502f-4a97-84c9-f173729c51d318

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-404-012502104040125 VIAL in 1 CARTON (25021-404-01) / 1 mL in 1 VIAL25 vial2010-07-060000-00-00NoNoCurrent