Oxybutynin Chloride

Product NDC
0378-6605
11-digit product format
003786605
Labeler code
0378
Product ID
0378-6605_c0c49bd6-f664-4d83-b04e-e3575e3492d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxybutynin chloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076702
Marketing category
ANDA
Marketing start
2006-11-10
Marketing end
2020-01-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6605-01EA - Each0378-66052caa9674-b260-45ab-b1cd-817633a6a9da12012-07-24
0378-6605-05EA - Each0378-6605774aa5c1-dcc5-4069-bd43-5e788e9cec6c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN82c40f61-91a1-4946-b63f-0251aa01740c1
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN32a742f5-a683-46ba-90dd-5778b2c003081
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN82c40f61-91a1-4946-b63f-0251aa01740c1
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD82c40f61-91a1-4946-b63f-0251aa01740c1
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD32a742f5-a683-46ba-90dd-5778b2c003081
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD82c40f61-91a1-4946-b63f-0251aa01740c1
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY82c40f61-91a1-4946-b63f-0251aa01740c1
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY32a742f5-a683-46ba-90dd-5778b2c003081
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY82c40f61-91a1-4946-b63f-0251aa01740c1