OXYBUTYNIN- oxybutynin tablet, film coated, extended release 
Cadila Healthcare Limited

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OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oxybutynin chloride extended-release tablets USP, 5 mg

NDC 70771-1086-3

30 tablets

Rx   only

Oxybutynin chloride extended-release tablets

Oxybutynin chloride extended-release tablets USP, 10 mg

NDC 70771-1087-3

30 tablets

Rx   only

Oxybutynin chloride extended-release tablets

Oxybutynin chloride extended-release tablets USP, 15 mg

NDC 70771-1088-3

30 tablets

Rx   only

Oxybutynin chloride extended-release tablets
OXYBUTYNIN 
oxybutynin tablet, film coated, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1086
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBUTYNIN CHLORIDE (UNII: L9F3D9RENQ) (OXYBUTYNIN - UNII:K9P6MC7092) OXYBUTYNIN CHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ALGINIC ACID (UNII: 8C3Z4148WZ)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code 255
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1086-330 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
2NDC:70771-1086-660 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
3NDC:70771-1086-990 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
4NDC:70771-1086-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
5NDC:70771-1086-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
6NDC:70771-1086-410 in 1 CARTON08/10/2017
6NDC:70771-1086-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20233208/10/2017
OXYBUTYNIN 
oxybutynin tablet, film coated, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1087
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBUTYNIN CHLORIDE (UNII: L9F3D9RENQ) (OXYBUTYNIN - UNII:K9P6MC7092) OXYBUTYNIN CHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ALGINIC ACID (UNII: 8C3Z4148WZ)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code 256
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1087-660 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
2NDC:70771-1087-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
3NDC:70771-1087-990 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
4NDC:70771-1087-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
5NDC:70771-1087-330 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
6NDC:70771-1087-410 in 1 CARTON08/10/2017
6NDC:70771-1087-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20233208/10/2017
OXYBUTYNIN 
oxybutynin tablet, film coated, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1088
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBUTYNIN CHLORIDE (UNII: L9F3D9RENQ) (OXYBUTYNIN - UNII:K9P6MC7092) OXYBUTYNIN CHLORIDE15 mg
Inactive Ingredients
Ingredient NameStrength
ALGINIC ACID (UNII: 8C3Z4148WZ)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code 257
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1088-660 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
2NDC:70771-1088-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
3NDC:70771-1088-990 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
4NDC:70771-1088-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
5NDC:70771-1088-330 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
6NDC:70771-1088-410 in 1 CARTON08/10/2017
6NDC:70771-1088-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20233208/10/2017
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(70771-1086, 70771-1087, 70771-1088) , MANUFACTURE(70771-1086, 70771-1087, 70771-1088)

Revised: 9/2020
Document Id: 38ac4e71-8edf-4dd1-ba35-8e84006d4b48
Set id: f405a774-bd91-4513-b7c7-c44f0596d988
Version: 5
Effective Time: 20200914
 
Cadila Healthcare Limited