Diphenhydramine Hydrochloride
Diphenhydramine Hydrochloride Injection, USP Rx only
Approved
Approval ID
2d51aae4-d1da-22bc-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 4, 2019
Manufacturers
FDA
Sina Health Inc
DUNS: 047161553
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 Code70385-2007
Application NumberANDA080817
Product Classification
M
Marketing Category
C73584
G
Generic Name
diphenhydramine hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateFebruary 4, 2019
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZETHONIUM CHLORIDEInactive
Quantity: 100 ug in 1 mL
Code: PH41D05744
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 mL
Code: TC2D6JAD40
Classification: ACTIB