Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
RedPharm Drug, Inc.
RedPharm Drug, Inc.
828374897
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
HYDROCODONE BITARTRATE AND IBUPROFEN
Product Details
NDC Product Code
67296-1282Application Number
ANDA076604Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 20, 2020HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 200 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HydrocodoneActive
Code: NO70W886KKClass: ACTIBQuantity: 7.5 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT