Home NDC 0517-4310 Desmopressin Acetate
Product NDC 0517-4310
11-digit product format 005174310
Labeler code 0517
Product ID 0517-4310_84de54d4-1a30-4820-97de-0f02cd1036dc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desmopressin Acetate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler American Regent, Inc.
Application ANDA091374
Marketing category ANDA
Marketing start 2020-12-31
Marketing end 0000-00-00
Substance DESMOPRESSIN ACETATE
Active strength 4 ug/mL
Pharmacologic classes Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0517-4310-01 00517431001 1 VIAL in 1 BOX (0517-4310-01) > 10 mL in 1 VIAL 1 vial 2020-12-31 0000-00-00 No No Current