Oxycodone and acetaminophen tablet

Ingredients and appearance - Product information

Oxycodone and acetaminophen tablet- Oxycodone hydrochloride and acetaminophen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0591-0749
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Oxycodone hydrochloride ( UNII: C1ENJ2TE6C)( Oxycodone - UNII: CD35PMG570 ) 5 mgin 1
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Starch, corn ( UNII: O8232NY3SJ)
Stearic acid ( UNII: 4ELV7Z65AP)

Product Characteristics

Color WHITE Imprint Code WATSON;749
Score 2 Shape ROUND
Size 11 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0591-0749-01 100 in 1 BOTTLE, PLASTIC 1997/10/30
2 NDC: 0591-0749-05 500 in 1 BOTTLE, PLASTIC 1997/10/30

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040171 USA 1997/10/30

Oxycodone and acetaminophen tablet- Oxycodone hydrochloride and acetaminophen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0591-0933
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Oxycodone hydrochloride ( UNII: C1ENJ2TE6C)( Oxycodone - UNII: CD35PMG570 ) 7.5 mgin 1
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Starch, corn ( UNII: O8232NY3SJ)
Stearic acid ( UNII: 4ELV7Z65AP)

Product Characteristics

Color WHITE Imprint Code WATSON;933
Score 1 Shape ROUND
Size 11 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0591-0933-01 100 in 1 BOTTLE, PLASTIC 2003/09/05
2 NDC: 0591-0933-05 500 in 1 BOTTLE, PLASTIC 2003/09/05

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040535 USA 2003/09/05

Oxycodone and acetaminophen tablet- Oxycodone hydrochloride and acetaminophen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0591-0824
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Oxycodone hydrochloride ( UNII: C1ENJ2TE6C)( Oxycodone - UNII: CD35PMG570 ) 7.5 mgin 1
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 500 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Starch, corn ( UNII: O8232NY3SJ)
Stearic acid ( UNII: 4ELV7Z65AP)
Croscarmellose sodium ( UNII: M28OL1HH48)
Povidone ( UNII: FZ989GH94E)

Product Characteristics

Color WHITE Imprint Code WATSON;824
Score 2 Shape OVAL (capsule shaped)
Size 17 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0591-0824-01 100 in 1 BOTTLE, PLASTIC 2000/12/29
2 NDC: 0591-0824-05 500 in 1 BOTTLE, PLASTIC 2000/12/29

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040371 USA 2000/12/29

Oxycodone and acetaminophen tablet- Oxycodone hydrochloride and acetaminophen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0591-0932
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Oxycodone hydrochloride ( UNII: C1ENJ2TE6C)( Oxycodone - UNII: CD35PMG570 ) 10 mgin 1
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Starch, corn ( UNII: O8232NY3SJ)
Stearic acid ( UNII: 4ELV7Z65AP)

Product Characteristics

Color WHITE Imprint Code WATSON;932
Score 1 Shape ROUND
Size 11 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0591-0932-01 100 in 1 BOTTLE, PLASTIC 2003/09/05
2 NDC: 0591-0932-05 500 in 1 BOTTLE, PLASTIC 2003/09/05

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040535 USA 2003/09/05

Oxycodone and acetaminophen tablet- Oxycodone hydrochloride and acetaminophen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0591-0825
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Oxycodone hydrochloride ( UNII: C1ENJ2TE6C)( Oxycodone - UNII: CD35PMG570 ) 10 mgin 1
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 650 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Starch, corn ( UNII: O8232NY3SJ)
Stearic acid ( UNII: 4ELV7Z65AP)
Croscarmellose sodium ( UNII: M28OL1HH48)
Povidone ( UNII: FZ989GH94E)

Product Characteristics

Color WHITE Imprint Code WATSON;825
Score 2 Shape OVAL (capsule shaped)
Size 16 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0591-0825-01 100 in 1 BOTTLE, PLASTIC 2000/12/29
2 NDC: 0591-0825-05 500 in 1 BOTTLE, PLASTIC 2000/12/29

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040371 USA 2000/12/29

Labeler - Actavis Pharma, Inc.( 119723554)

Establishment

Name ID/FEI Business Operations
Actavis Pharma, Inc. 119723554 ANALYSIS( 0591-0749, 0591-0933, 0591-0824, 0591-0932, 0591-0825), LABEL( 0591-0749, 0591-0933, 0591-0824, 0591-0932, 0591-0825), MANUFACTURE( 0591-0749, 0591-0933, 0591-0824, 0591-0932, 0591-0825), PACK( 0591-0749, 0591-0933, 0591-0824, 0591-0932, 0591-0825)