Propranolol
Propranolol Hydrochloride Injection USP
Approved
Approval ID
f14ea537-dd5c-4c78-9037-9a85e9e610ef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2023
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.
PROPRANOLOL HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-604
Application NumberANDA075826
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROPRANOLOL HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 23, 2020
FDA Product Classification
INGREDIENTS (2)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: F8A3652H1V
Classification: ACTIB
Drug Labeling Information
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 1/12/2023
HOW SUPPLIED
Propranolol Hydrochloride Injection, USP,
1 mg per mL is supplied as follows:
|
Product |
Unit of Sale |
Strength |
Each |
|
600401 |
NDC 63323-604-01 |
1 mg per mL |
NDC 63323-604-00 |
The container closure is not made with natural rubber latex.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from freezing and excessive heat.