Hydralazine Hydrochloride
Approved
Approval ID
04b4c1c2-093c-4f48-a6b4-3e290fae51b4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 16, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
hydralazine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6266
Application NumberANDA040730
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydralazine hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJune 16, 2011
FDA Product Classification
INGREDIENTS (7)
METHYLPARABENInactive
Quantity: 0.65 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.35 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
HYDRALAZINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: FD171B778Y
Classification: ACTIB
PROPYLENE GLYCOLInactive
Quantity: 103.6 mg in 1 mL
Code: 6DC9Q167V3
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT