Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
American Health Packaging
American Health Packaging
929561009
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxazepam
Product Details
NDC Product Code
62584-812Application Number
ANDA072253Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 2, 2023CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
OxazepamActive
Code: 6GOW6DWN2AClass: ACTIBQuantity: 10 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Oxazepam
Product Details
NDC Product Code
62584-813Application Number
ANDA072253Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 2, 2023CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
OxazepamActive
Code: 6GOW6DWN2AClass: ACTIBQuantity: 15 mg in 1 1
Oxazepam
Product Details
NDC Product Code
62584-814Application Number
ANDA072253Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 2, 2023CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
OxazepamActive
Code: 6GOW6DWN2AClass: ACTIBQuantity: 30 mg in 1 1
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT