Diphenhydramine Hydrochloride
Diphenhydramine Hydrochloride Capsules, USP
Approved
Approval ID
c3be33a2-b7eb-4826-9c0c-9de24d54c173
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 5, 2010
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DIPHENHYDRAMINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-127
Application NumberANDA080738
Product Classification
M
Marketing Category
C73584
G
Generic Name
DIPHENHYDRAMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2010
FDA Product Classification
INGREDIENTS (14)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: TC2D6JAD40
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT