DIPHENHYDRAMINE HCI
DIPHENHYDRAMINE HCI INJECTION, USP 50mg/mL 1mL CARP
Approved
Approval ID
7b05c2ef-24eb-f754-e053-2991aa0afbae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 19, 2020
Manufacturers
FDA
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DIPHENHYDRAMINE HCI
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51662-1218
Application NumberANDA040140
Product Classification
M
Marketing Category
C73584
G
Generic Name
DIPHENHYDRAMINE HCI
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateFebruary 19, 2020
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 mL
Code: TC2D6JAD40
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT