Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
State of Florida DOH Central Pharmacy
State of Florida DOH Central Pharmacy
829348114
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diphenhydramine Hydrochloride
Product Details
NDC Product Code
53808-0238Application Number
ANDA080738Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 25, 2010FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
DiphenhydramineActive
Code: TC2D6JAD40Class: ACTIBQuantity: 50 mg in 1 1
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT