DIPHENHYDRAMINE
Approved
Approval ID
a1110433-498a-48cb-ac79-5732fd4f8fba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 28, 2022
Manufacturers
FDA
Micro Labs Limited
DUNS: 862174955
Products 2
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 Code42571-169
Application NumberANDA205723
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diphenhydramine Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateNovember 28, 2022
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 mL
Code: TC2D6JAD40
Classification: ACTIB
Diphenhydramine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42571-337
Application NumberANDA205723
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diphenhydramine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateNovember 28, 2022
FDA Product Classification
INGREDIENTS (4)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 mL
Code: TC2D6JAD40
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT