Desmopressin Acetate

Product NDC
68382-384
11-digit product format
683820384
Labeler code
68382
Product ID
68382-384_d1257ed5-d032-4453-98b4-e9f791a6cbdf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desmopressin Acetate
Dosage form
SPRAY
Route
NASAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA091345
Marketing category
ANDA
Marketing start
2018-02-01
Marketing end
0000-00-00
Substance
DESMOPRESSIN ACETATE
Active strength
0 mg/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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-384-01ML - Milliliter68382-38463596947-75b2-44f5-a0e7-dbbf04fa49b912019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-384-01683820384015 mL in 1 BOTTLE, SPRAY (68382-384-01) 5 ml2018-02-010000-00-00NoNoCurrent