Hydrocodone bitartrate and ibuprofen tablet, film coated

Ingredients and appearance - Product information

Hydrocodone bitartrate and ibuprofen tablet, film coated- Hydrocodone bitartrate and ibuprofen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 43063-349
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Hydrocodone bitartrate ( UNII: NO70W886KK)( Hydrocodone - UNII: 6YKS4Y3WQ7 ) 7.5 mgin 1
Ibuprofen ( UNII: WK2XYI10QM)( Ibuprofen - UNII: WK2XYI10QM ) 200 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Croscarmellose sodium ( UNII: M28OL1HH48)
Hypromellose 2910 (3 mpa.s) ( UNII: 0VUT3PMY82)
Hypromellose 2910 (6 mpa.s) ( UNII: 0WZ8WG20P6)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Polyethylene glycol 8000 ( UNII: Q662QK8M3B)
Polydextrose ( UNII: VH2XOU12IE)
Starch, corn ( UNII: O8232NY3SJ)
Titanium dioxide ( UNII: 15FIX9V2JP)
Triacetin ( UNII: XHX3C3X673)

Product Characteristics

Color white Imprint Code 524
Score 1 Shape ROUND
Size 10 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 43063-349-15 15 in 1 BOTTLE, PLASTIC 2017/01/27
2 NDC: 43063-349-20 20 in 1 BOTTLE, PLASTIC 2017/03/01
3 NDC: 43063-349-30 30 in 1 BOTTLE, PLASTIC 2017/02/09
4 NDC: 43063-349-60 60 in 1 BOTTLE, PLASTIC 2012/03/09

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076604 USA 2012/03/09

Labeler - PD-Rx Pharmaceuticals, Inc.( 156893695)

Establishment

Name ID/FEI Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack( 43063-349)