PAPAVERINE HYDROCHLORIDE
This product is to be used by or under the direction of a physician. Each vial contains a sufficient amount to permit withdrawal and administration of the volume specified on the label.
Approved
Approval ID
6f16f2ed-8e1c-4c6f-bd1d-846e02b1be97
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2023
Manufacturers
FDA
BPI Labs LLC
DUNS: 078627620
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Papaverine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54288-142
Product Classification
G
Generic Name
Papaverine Hydrochloride
Product Specifications
Route of AdministrationPARENTERAL, INTRAVENOUS, INTRAMUSCULAR
Effective DateApril 26, 2023
FDA Product Classification
INGREDIENTS (6)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PAPAVERINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 mL
Code: 23473EC6BQ
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT