Diphenhydramine
DiphenhydrAMINE Hydrochloride Injection, USP
Approved
Approval ID
fc574e74-1fdc-4a61-a1ed-492ae43faed2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 3, 2019
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
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 Code63323-664
Application NumberANDA040466
Product Classification
M
Marketing Category
C73584
G
Generic Name
DIPHENHYDRAMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateOctober 3, 2019
FDA Product Classification
INGREDIENTS (3)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 mL
Code: TC2D6JAD40
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT