Dimenhydrinate
Dimenhydrinate Injection USP
Approved
Approval ID
bc71539e-1a33-4709-8a24-c2894e8dbc1c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 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.
Dimenhydrinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-366
Application NumberANDA040519
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dimenhydrinate
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateDecember 31, 2019
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 0.05 mL in 1 mL
Code: LKG8494WBH
Classification: IACT
PROPYLENE GLYCOLInactive
Quantity: 0.5 mL in 1 mL
Code: 6DC9Q167V3
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
DIMENHYDRINATEActive
Quantity: 50 mg in 1 mL
Code: JB937PER5C
Classification: ACTIB