Label: OXYBUTYNIN tablet, film coated, extended release
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NDC Code(s):
70771-1086-1,
70771-1086-2,
70771-1086-3,
70771-1086-4, view more70771-1086-5, 70771-1086-6, 70771-1086-9, 70771-1087-1, 70771-1087-2, 70771-1087-3, 70771-1087-4, 70771-1087-5, 70771-1087-6, 70771-1087-9, 70771-1088-1, 70771-1088-2, 70771-1088-3, 70771-1088-4, 70771-1088-5, 70771-1088-6, 70771-1088-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 31, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OXYBUTYNIN
oxybutynin tablet, film coated, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1086 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBUTYNIN CHLORIDE (UNII: L9F3D9RENQ) (OXYBUTYNIN - UNII:K9P6MC7092) OXYBUTYNIN CHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength 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 Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 7mm Flavor Imprint Code 255 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1086-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 2 NDC:70771-1086-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 3 NDC:70771-1086-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 4 NDC:70771-1086-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 5 NDC:70771-1086-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 6 NDC:70771-1086-4 10 in 1 CARTON 08/10/2017 6 NDC:70771-1086-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202332 08/10/2017 OXYBUTYNIN
oxybutynin tablet, film coated, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1087 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBUTYNIN CHLORIDE (UNII: L9F3D9RENQ) (OXYBUTYNIN - UNII:K9P6MC7092) OXYBUTYNIN CHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength 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 Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 7mm Flavor Imprint Code 256 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1087-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 2 NDC:70771-1087-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 3 NDC:70771-1087-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 4 NDC:70771-1087-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 5 NDC:70771-1087-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 6 NDC:70771-1087-4 10 in 1 CARTON 08/10/2017 6 NDC:70771-1087-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202332 08/10/2017 OXYBUTYNIN
oxybutynin tablet, film coated, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1088 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBUTYNIN CHLORIDE (UNII: L9F3D9RENQ) (OXYBUTYNIN - UNII:K9P6MC7092) OXYBUTYNIN CHLORIDE 15 mg Inactive Ingredients Ingredient Name Strength 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 Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 7mm Flavor Imprint Code 257 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1088-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 2 NDC:70771-1088-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 3 NDC:70771-1088-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 4 NDC:70771-1088-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 5 NDC:70771-1088-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 6 NDC:70771-1088-4 10 in 1 CARTON 08/10/2017 6 NDC:70771-1088-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202332 08/10/2017 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1086, 70771-1087, 70771-1088) , MANUFACTURE(70771-1086, 70771-1087, 70771-1088)
