FDA.reportPublic FDA data

Heparin Sodium

Product NDC
65219-066
11-digit product format
652190066
Labeler code
65219
Product ID
65219-066_f9aafe50-c679-4991-93ab-1866d5b19c8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HEPARIN SODIUM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA017029
Marketing category
NDA
Marketing start
2022-03-22
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPARIN SODIUM1000 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui1361226

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
65219-066-01Heparin Sodium1 mL in 1 VIALINJECTION, SOLUTION12
65219-066-10Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-066-01ML - Milliliter65219-066b6ab1991-6ce0-4392-ba99-2bafeea9757912025-10-14
65219-066-10ML - Milliliter65219-0667b7ebb5e-bb6c-45a4-8c99-3cdd7c45243612025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-066HEPARIN SODIUM (HEPARIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2Current NDC, Legacy NDC, 2 package rows20240119_a120bdfd-21e1-4024-82a7-13cfeed290c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSNa120bdfd-21e1-4024-82a7-13cfeed290c12
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCDa120bdfd-21e1-4024-82a7-13cfeed290c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65219-066-01652190066011 mL in 1 VIAL1 mlHistorical
65219-066-106521900661025 VIAL in 1 TRAY (65219-066-10) / 1 mL in 1 VIAL (65219-066-01) 25 vial2022-03-220000-00-00NoNoCurrent