Heparin Sodium

Product NDC
68083-428
11-digit product format
680830428
Labeler code
68083
Product ID
68083-428_794ab494-666a-4e82-ba24-982189a20255
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Gland Pharma Limited
Application
ANDA205323
Marketing category
ANDA
Marketing start
2019-11-18
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
ZZ45AB24CAHEPARIN SODIUM9041-08-1HEPARIN SODIUM

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68083-428-256808304282525 VIAL, MULTI-DOSE in 1 CARTON (68083-428-25) / 30 mL in 1 VIAL, MULTI-DOSE (68083-428-01) 2019-11-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Heparin SodiumGland Pharma Limited2024-11-13Human Prescription Drug Label12