Oxycodone and acetaminophen tablet

Ingredients and appearance - Product information

Oxycodone and acetaminophen tablet- Oxycodone and acetaminophen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50436-2982
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
Croscarmellose sodium ( UNII: M28OL1HH48)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Povidone, unspecified ( UNII: FZ989GH94E)
Starch, corn ( UNII: O8232NY3SJ)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Stearic acid ( UNII: 4ELV7Z65AP)

Product Characteristics

Color WHITE (White to off-white) Imprint Code A332
Score 1 Shape OVAL (capsule-shaped)
Size 14 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50436-2982-1 30 in 1 BOTTLE 2017/05/01
2 NDC: 50436-2982-2 60 in 1 BOTTLE 2017/05/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA201447 USA 2017/05/01

Oxycodone and acetaminophen tablet- Oxycodone and acetaminophen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50436-2983
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
Croscarmellose sodium ( UNII: M28OL1HH48)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Povidone, unspecified ( UNII: FZ989GH94E)
Starch, corn ( UNII: O8232NY3SJ)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Stearic acid ( UNII: 4ELV7Z65AP)

Product Characteristics

Color WHITE (White to off-white) Imprint Code A333
Score 1 Shape OVAL (modified capsule-shaped)
Size 15 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50436-2983-1 30 in 1 BOTTLE 2017/05/01
2 NDC: 50436-2983-2 60 in 1 BOTTLE 2017/05/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA201447 USA 2017/05/01

Oxycodone and acetaminophen tablet- Oxycodone and acetaminophen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50436-3913
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
Croscarmellose sodium ( UNII: M28OL1HH48)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Povidone, unspecified ( UNII: FZ989GH94E)
Starch, corn ( UNII: O8232NY3SJ)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Stearic acid ( UNII: 4ELV7Z65AP)

Product Characteristics

Color WHITE (White to off-white) Imprint Code A349
Score 2 Shape ROUND
Size 12 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50436-3913-1 30 in 1 BOTTLE 2013/12/10
2 NDC: 50436-3913-2 60 in 1 BOTTLE 2013/12/10
3 NDC: 50436-3913-3 90 in 1 BOTTLE 2013/12/10
4 NDC: 50436-3913-5 24 in 1 BOTTLE 2018/08/07

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA201447 USA 2018/08/07

Labeler - Unit Dose Services( 831995316)

Establishment

Name ID/FEI Business Operations
Unit Dose Services 831995316 REPACK( 50436-3913, 50436-2982, 50436-2983), RELABEL( 50436-2982, 50436-2983, 50436-3913)

Oxycodone and acetaminophen tablet

Oxycodone and acetaminophen tablet

Oxycodone and acetaminophen tablet