Oxybutynin Chloride

Product NDC
14539-653
11-digit product format
145390653
Labeler code
14539
Product ID
14539-653_5702ab99-0517-411e-9fb1-d6b1f415a790
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA211682
Marketing category
ANDA
Marketing start
2019-06-01
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
14539-653-01EA - Each14539-653574642ca-f7e1-4fb3-85b5-b75b2f3ddd1412019-10-07
14539-653-05EA - Each14539-6532a64cc54-a113-4470-a29a-57434c8c66d112019-10-07
14539-653-10EA - Each14539-653eefd8063-544c-4d5d-bb28-f620fc726cd912019-10-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14539-653-0114539065301100 TABLET in 1 BOTTLE, PLASTIC (14539-653-01) 100 tablet2019-06-010000-00-00NoNoCurrent
14539-653-0514539065305500 TABLET in 1 BOTTLE, PLASTIC (14539-653-05) 500 tablet2019-06-010000-00-00NoNoCurrent
14539-653-10145390653101000 TABLET in 1 BOTTLE, PLASTIC (14539-653-10) 1000 tablet2019-06-010000-00-00NoNoCurrent