Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Genus Lifesciences Inc.
Genus Lifesciences Inc.
113290444
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocodone Bitartrate and Homatropine Methylbromide
Product Details
NDC Product Code
64950-371Application Number
NDA005213Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
June 1, 2022HydrocodoneActive
Code: NO70W886KKClass: ACTIBQuantity: 5 mg in 5 mL
Code: 68JRS2HC1CClass: ACTIBQuantity: 1.5 mg in 5 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
CHERRYInactive
Code: BUC5I9595WClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
Hydrocodone Bitartrate and Homatropine Methylbromide
Product Details
NDC Product Code
64950-206Application Number
NDA005213Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
June 1, 2022Code: 68JRS2HC1CClass: ACTIBQuantity: 1.5 mg in 1 1
HydrocodoneActive
Code: NO70W886KKClass: ACTIBQuantity: 5 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT