Ropinirole hydrochloride tablet, film coated, extended release

Ingredients and appearance - Product information

Ropinirole hydrochloride tablet, film coated, extended release- Ropinirole hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0591-3611
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ropinirole hydrochloride ( UNII: D7ZD41RZI9)( Ropinirole - UNII: 030PYR8953 ) 2 mgin 1

Inactive Ingredients

Ingredient Name Code
Hypromelloses ( UNII: 3NXW29V3WO)
Mannitol ( UNII: 3OWL53L36A)
Glyceryl dibehenate ( UNII: R8WTH25YS2)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Hydrogenated castor oil ( UNII: ZF94AP8MEY)
Povidone ( UNII: FZ989GH94E)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Talc ( UNII: 7SEV7J4R1U)
Magnesium stearate ( UNII: 70097M6I30)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Triethyl citrate ( UNII: 8Z96QXD6UM)
Titanium dioxide ( UNII: 15FIX9V2JP)
Polydextrose ( UNII: VH2XOU12IE)
Triacetin ( UNII: XHX3C3X673)
Polyethylene glycol 8000 ( UNII: Q662QK8M3B)
Ferric oxide red ( UNII: 1K09F3G675)
Ferric oxide yellow ( UNII: EX438O2MRT)
Vinyl acetate ( UNII: L9MK238N77)

Product Characteristics

Color PINK Imprint Code WATSON;3611
Score 1 Shape OVAL
Size 13 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0591-3611-05 500 in 1 BOTTLE, PLASTIC 2012/06/06
2 NDC: 0591-3611-19 90 in 1 BOTTLE, PLASTIC 2012/06/06
3 NDC: 0591-3611-30 30 in 1 BOTTLE, PLASTIC 2012/06/06

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA200431 USA 2012/06/06

Ropinirole hydrochloride tablet, film coated, extended release- Ropinirole hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0591-3613
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ropinirole hydrochloride ( UNII: D7ZD41RZI9)( Ropinirole - UNII: 030PYR8953 ) 4 mgin 1

Inactive Ingredients

Ingredient Name Code
Hypromelloses ( UNII: 3NXW29V3WO)
Mannitol ( UNII: 3OWL53L36A)
Glyceryl dibehenate ( UNII: R8WTH25YS2)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Hydrogenated castor oil ( UNII: ZF94AP8MEY)
Povidone ( UNII: FZ989GH94E)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Talc ( UNII: 7SEV7J4R1U)
Magnesium stearate ( UNII: 70097M6I30)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Triethyl citrate ( UNII: 8Z96QXD6UM)
Titanium dioxide ( UNII: 15FIX9V2JP)
Polydextrose ( UNII: VH2XOU12IE)
Triacetin ( UNII: XHX3C3X673)
Polyethylene glycol 8000 ( UNII: Q662QK8M3B)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Aluminum oxide ( UNII: LMI26O6933)
Vinyl acetate ( UNII: L9MK238N77)

Product Characteristics

Color BROWN (beige) Imprint Code WATSON;3613
Score 1 Shape OVAL
Size 13 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0591-3613-05 500 in 1 BOTTLE, PLASTIC 2012/06/06
2 NDC: 0591-3613-19 90 in 1 BOTTLE, PLASTIC 2012/06/06
3 NDC: 0591-3613-30 30 in 1 BOTTLE, PLASTIC 2012/06/06

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA200431 USA 2012/06/06

Ropinirole hydrochloride tablet, film coated, extended release- Ropinirole hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0591-3700
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ropinirole hydrochloride ( UNII: D7ZD41RZI9)( Ropinirole - UNII: 030PYR8953 ) 6 mgin 1

Inactive Ingredients

Ingredient Name Code
Hypromelloses ( UNII: 3NXW29V3WO)
Mannitol ( UNII: 3OWL53L36A)
Glyceryl dibehenate ( UNII: R8WTH25YS2)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Hydrogenated castor oil ( UNII: ZF94AP8MEY)
Povidone ( UNII: FZ989GH94E)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Talc ( UNII: 7SEV7J4R1U)
Magnesium stearate ( UNII: 70097M6I30)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Triethyl citrate ( UNII: 8Z96QXD6UM)
Titanium dioxide ( UNII: 15FIX9V2JP)
Polydextrose ( UNII: VH2XOU12IE)
Triacetin ( UNII: XHX3C3X673)
Polyethylene glycol 8000 ( UNII: Q662QK8M3B)
Vinyl acetate ( UNII: L9MK238N77)

Product Characteristics

Color WHITE Imprint Code WATSON;3700
Score 1 Shape OVAL
Size 13 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0591-3700-05 500 in 1 BOTTLE, PLASTIC 2012/06/06
2 NDC: 0591-3700-19 90 in 1 BOTTLE, PLASTIC 2012/06/06
3 NDC: 0591-3700-30 30 in 1 BOTTLE, PLASTIC 2012/06/06

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA200431 USA 2012/06/06

Ropinirole hydrochloride tablet, film coated, extended release- Ropinirole hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0591-3614
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ropinirole hydrochloride ( UNII: D7ZD41RZI9)( Ropinirole - UNII: 030PYR8953 ) 8 mgin 1

Inactive Ingredients

Ingredient Name Code
Hypromelloses ( UNII: 3NXW29V3WO)
Mannitol ( UNII: 3OWL53L36A)
Glyceryl dibehenate ( UNII: R8WTH25YS2)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Hydrogenated castor oil ( UNII: ZF94AP8MEY)
Povidone ( UNII: FZ989GH94E)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Talc ( UNII: 7SEV7J4R1U)
Magnesium stearate ( UNII: 70097M6I30)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Triethyl citrate ( UNII: 8Z96QXD6UM)
Titanium dioxide ( UNII: 15FIX9V2JP)
Polydextrose ( UNII: VH2XOU12IE)
Triacetin ( UNII: XHX3C3X673)
Polyethylene glycol 8000 ( UNII: Q662QK8M3B)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Aluminum oxide ( UNII: LMI26O6933)
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Vinyl acetate ( UNII: L9MK238N77)

Product Characteristics

Color RED Imprint Code WATSON;3614
Score 1 Shape OVAL
Size 13 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0591-3614-05 500 in 1 BOTTLE, PLASTIC 2012/06/06
2 NDC: 0591-3614-19 90 in 1 BOTTLE, PLASTIC 2012/06/06
3 NDC: 0591-3614-30 30 in 1 BOTTLE, PLASTIC 2012/06/06

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA200431 USA 2012/06/06

Ropinirole hydrochloride tablet, film coated, extended release- Ropinirole hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0591-3612
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ropinirole hydrochloride ( UNII: D7ZD41RZI9)( Ropinirole - UNII: 030PYR8953 ) 12 mgin 1

Inactive Ingredients

Ingredient Name Code
Hypromelloses ( UNII: 3NXW29V3WO)
Mannitol ( UNII: 3OWL53L36A)
Glyceryl dibehenate ( UNII: R8WTH25YS2)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Hydrogenated castor oil ( UNII: ZF94AP8MEY)
Povidone ( UNII: FZ989GH94E)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Talc ( UNII: 7SEV7J4R1U)
Magnesium stearate ( UNII: 70097M6I30)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Triethyl citrate ( UNII: 8Z96QXD6UM)
Titanium dioxide ( UNII: 15FIX9V2JP)
Polydextrose ( UNII: VH2XOU12IE)
Triacetin ( UNII: XHX3C3X673)
Polyethylene glycol 8000 ( UNII: Q662QK8M3B)
Ferric oxide yellow ( UNII: EX438O2MRT)
Aluminum oxide ( UNII: LMI26O6933)
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Vinyl acetate ( UNII: L9MK238N77)

Product Characteristics

Color GREEN Imprint Code WATSON;3612
Score 1 Shape OVAL
Size 13 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0591-3612-05 500 in 1 BOTTLE, PLASTIC 2012/06/06
2 NDC: 0591-3612-19 90 in 1 BOTTLE, PLASTIC 2012/06/06
3 NDC: 0591-3612-30 30 in 1 BOTTLE, PLASTIC 2012/06/06

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA200431 USA 2012/06/06

Labeler - Actavis Pharma, Inc.( 119723554)

Establishment

Name ID/FEI Business Operations
Actavis Pharma, Inc. 119723554 ANALYSIS( 0591-3611, 0591-3613, 0591-3613, 0591-3700, 0591-3614, 0591-3612), LABEL( 0591-3611, 0591-3613, 0591-3613, 0591-3700, 0591-3614, 0591-3612), MANUFACTURE( 0591-3611, 0591-3613, 0591-3700, 0591-3614, 0591-3612), PACK( 0591-3611, 0591-3613, 0591-3613, 0591-3700, 0591-3614, 0591-3612)