Hydrocodone Bitartrate and Ibuprofen (Page 11 of 11)

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HYDROCODONE BITARTRATE AND IBUPROFEN
hydrocodone bitartrate and ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-116
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 2.5 mg
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
TITANIUM DIOXIDE
POLYDEXTROSE
Product Characteristics
Color white Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code IP116
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-116-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076642 02/18/2010
HYDROCODONE BITARTRATE AND IBUPROFEN
hydrocodone bitartrate and ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-146
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 5 mg
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
TITANIUM DIOXIDE
POLYDEXTROSE
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 14mm
Flavor Imprint Code IP;146
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-146-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076642 02/18/2010
HYDROCODONE BITARTRATE AND IBUPROFEN
hydrocodone bitartrate and ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-145
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 7.5 mg
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
TITANIUM DIOXIDE
POLYDEXTROSE
Product Characteristics
Color white Score no score
Shape ROUND (Biconvex) Size 10mm
Flavor Imprint Code IP;145
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-145-01 100 TABLET in 1 BOTTLE None
2 NDC:53746-145-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076642 02/18/2010
HYDROCODONE BITARTRATE AND IBUPROFEN
hydrocodone bitartrate and ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-117
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 10 mg
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
TITANIUM DIOXIDE
POLYDEXTROSE
TRIACETIN
D&C YELLOW NO. 10
Product Characteristics
Color yellow Score no score
Shape ROUND (Biconvex) Size 10mm
Flavor Imprint Code IP;145
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-117-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076642 02/18/2010
Labeler — Amneal Pharmaceuticals of New York LLC (123797875)

Revised: 11/2022 Amneal Pharmaceuticals of New York LLC

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