Oxybutynin Chloride

Product NDC
64380-190
11-digit product format
643800190
Labeler code
64380
Product ID
64380-190_289e5f8b-6604-47a3-a3af-e2309972ba7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxybutynin chloride
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA075079
Marketing category
ANDA
Marketing start
2026-04-10
Substance
OXYBUTYNIN CHLORIDE
Active strength
2.5 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxybutynin Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBUTYNIN CHLORIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL9F3D9RENQ
Rxcui863664, 863758

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
982338c6-c45c-b6b4-1452-14b01fbdf98dProduct name220180801
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6Product name220171212
3544f362-07fc-93b1-457b-1fba00be087aProduct name220171212
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-190-01Oxybutynin Chloride100 in 1 BOTTLETABLET1006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863758oxyBUTYnin chloride 2.5 MG Oral TabletPSN9ede5def-d185-4e40-9c10-8663ac654caf6
863664oxyBUTYnin chloride 5 MG Oral TabletPSN9ede5def-d185-4e40-9c10-8663ac654caf6
863758oxybutynin chloride 2.5 MG Oral TabletSCD9ede5def-d185-4e40-9c10-8663ac654caf6
863664oxybutynin chloride 5 MG Oral TabletSCD9ede5def-d185-4e40-9c10-8663ac654caf6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64380-190-0164380019001100 TABLET in 1 BOTTLE (64380-190-01) 100 tablet2026-04-10NoNoCurrent