FDA.reportPublic FDA data

Heparin Sodium

Product NDC
25021-400
11-digit product format
250210400
Labeler code
25021
Product ID
25021-400_85f6b6fe-5b2b-41fb-95a6-7980520a6525
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA090808
Marketing category
ANDA
Marketing start
2010-07-06
Substance
HEPARIN SODIUM
Active strength
1000 [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 SODIUM1000 [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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-400-01Heparin Sodium25 in 1 CARTONINJECTION, SOLUTION2525
25021-400-01Heparin Sodium1 mL in 1 VIALINJECTION, SOLUTION125
25021-400-10Heparin Sodium10 mL in 1 VIALINJECTION, SOLUTION1025
25021-400-10Heparin Sodium25 in 1 CARTONINJECTION, SOLUTION2525
25021-400-30Heparin Sodium30 mL in 1 VIALINJECTION, SOLUTION3025
25021-400-30Heparin Sodium25 in 1 CARTONINJECTION, SOLUTION2525
25021-400-66Heparin Sodium1 mL in 1 VIALINJECTION, SOLUTION17
25021-400-66Heparin Sodium25 in 1 CARTONINJECTION, SOLUTION257
25021-400-67Heparin Sodium25 in 1 CARTONINJECTION, SOLUTION257
25021-400-67Heparin Sodium10 mL in 1 VIALINJECTION, SOLUTION107
25021-400-68Heparin Sodium30 mL in 1 VIALINJECTION, SOLUTION307
25021-400-68Heparin Sodium25 in 1 CARTONINJECTION, SOLUTION257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-400-01ML - Milliliter25021-400175cafea-db95-4c46-b59a-325a2d17263c12012-07-24
25021-400-10ML - Milliliter25021-400c6b04951-a684-481c-a090-a1c2d1d8dd9312012-07-24
25021-400-30ML - Milliliter25021-400b3d29187-2b37-49f8-86ce-54517c89b0e512012-07-24
25021-400-66ML - Milliliter25021-400e9bab2aa-96a2-413d-aa7f-acb6054b478212015-06-09
25021-400-67ML - Milliliter25021-4000a77d67f-9597-45ef-9473-59d8ed15ef4512014-09-03
25021-400-68ML - Milliliter25021-400756b3108-7dd0-4253-ba8e-2ca446ff9a7712024-07-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Heparin SodiumACTIVE INGREDIENTZZ45AB24CAHEPARIN SODIUM INJECTION [SAGENT PHARMACETICALS]19
HeparinACTIVE MOIETYT2410KM04AHEPARIN SODIUM INJECTION [SAGENT PHARMACETICALS]19
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHHEPARIN SODIUM INJECTION [SAGENT PHARMACETICALS]19
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBHEPARIN SODIUM INJECTION [SAGENT PHARMACETICALS]19
NitrogenINACTIVE INGREDIENTN762921K75HEPARIN SODIUM INJECTION [SAGENT PHARMACETICALS]19
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XHEPARIN SODIUM INJECTION [SAGENT PHARMACETICALS]19
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IHEPARIN SODIUM INJECTION [SAGENT PHARMACETICALS]19
WaterINACTIVE INGREDIENT059QF0KO0RHEPARIN SODIUM INJECTION [SAGENT PHARMACETICALS]19
Heparin SodiumACTIVE INGREDIENTZZ45AB24CAHEPARIN SODIUM INJECTION [SAGENT PHARMACETICALS]2
HeparinACTIVE MOIETYT2410KM04AHEPARIN SODIUM INJECTION [SAGENT PHARMACETICALS]2
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHHEPARIN SODIUM INJECTION [SAGENT PHARMACETICALS]2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBHEPARIN SODIUM INJECTION [SAGENT PHARMACETICALS]2
NitrogenINACTIVE INGREDIENTN762921K75HEPARIN SODIUM INJECTION [SAGENT PHARMACETICALS]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XHEPARIN SODIUM INJECTION [SAGENT PHARMACETICALS]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IHEPARIN SODIUM INJECTION [SAGENT PHARMACETICALS]2
WaterINACTIVE INGREDIENT059QF0KO0RHEPARIN SODIUM INJECTION [SAGENT PHARMACETICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-400HEPARIN SODIUM INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]25Current NDC, Legacy NDC, 6 package rows20240511_8ebe4b4d-cb28-47e8-9598-6105d250b3d2.zip
25021-400HEPARIN SODIUM INJECTION, SOLUTION [SAGENT PHARMACETICALS]7Current NDC, Legacy NDC, 6 package rows20240614_ef309d83-7262-4874-8580-f4ca254f963a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionPSN8ebe4b4d-cb28-47e8-9598-6105d250b3d225
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSN8ebe4b4d-cb28-47e8-9598-6105d250b3d225
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionPSN8ebe4b4d-cb28-47e8-9598-6105d250b3d225
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCD8ebe4b4d-cb28-47e8-9598-6105d250b3d225
1362831heparin sodium, porcine 10000 UNT/ML Injectable SolutionSCD8ebe4b4d-cb28-47e8-9598-6105d250b3d225
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionSCD8ebe4b4d-cb28-47e8-9598-6105d250b3d225
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionSY8ebe4b4d-cb28-47e8-9598-6105d250b3d225
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionPSNef309d83-7262-4874-8580-f4ca254f963a7
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSNef309d83-7262-4874-8580-f4ca254f963a7
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionPSNef309d83-7262-4874-8580-f4ca254f963a7
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCDef309d83-7262-4874-8580-f4ca254f963a7
1362831heparin sodium, porcine 10000 UNT/ML Injectable SolutionSCDef309d83-7262-4874-8580-f4ca254f963a7
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionSCDef309d83-7262-4874-8580-f4ca254f963a7
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionSYef309d83-7262-4874-8580-f4ca254f963a7
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSN463e0624-b8c3-386b-e063-6294a90afd281
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCD463e0624-b8c3-386b-e063-6294a90afd281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-400-012502104000125 VIAL in 1 CARTON (25021-400-01) / 1 mL in 1 VIAL25 vial2010-07-060000-00-00NoNoCurrent
25021-400-102502104001025 VIAL in 1 CARTON (25021-400-10) / 10 mL in 1 VIAL25 vial2010-07-060000-00-00NoNoCurrent
25021-400-302502104003025 VIAL in 1 CARTON (25021-400-30) / 30 mL in 1 VIAL25 vial2010-07-060000-00-00NoNoCurrent
25021-400-662502104006625 VIAL in 1 CARTON (25021-400-66) / 1 mL in 1 VIAL25 vial2014-07-01NoNoHistorical
25021-400-672502104006725 VIAL in 1 CARTON (25021-400-67) / 10 mL in 1 VIAL25 vial2014-07-01NoNoHistorical
25021-400-682502104006825 VIAL in 1 CARTON (25021-400-68) / 30 mL in 1 VIAL25 vial2024-06-01NoNoHistorical