Oxybutynin Chloride

Product NDC
69452-119
11-digit product format
694520119
Labeler code
69452
Product ID
69452-119_e6dd7ccd-4715-8af8-e053-2a95a90aa6b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA210717
Marketing category
ANDA
Marketing start
2020-03-16
Marketing end
0000-00-00
Substance
OXYBUTYNIN CHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
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
69452-119-20EA - Each69452-119c0d6a221-fe46-46a7-9b65-d28e520c318412020-09-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69452-119-2069452011920100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69452-119-20) 2020-03-160000-00-00NoNoCurrent