Diphenhydramine Hydrochloride
DiphenhydrAMINE Hydrochloride Injection, USP
Approved
Approval ID
50df93bf-fe72-48f6-a02e-ea9a313d47c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2024
Manufacturers
FDA
Cardinal Health 107, LLC
DUNS: 118546603
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 Code55154-9363
Application NumberANDA040466
Product Classification
M
Marketing Category
C73584
G
Generic Name
diphenhydramine hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 30, 2019
FDA Product Classification
INGREDIENTS (7)
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
diphenhydramine hydrochlorideActive
Quantity: 50 mg in 1 mL
Code: TC2D6JAD40
Classification: ACTIB
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 mL
Code: TC2D6JAD40
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM