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Propranolol Hydrochloride

Propranolol Hydrochloride Tablets, USP

Approved
Approval ID

7bcb754b-df3e-4a8d-98aa-8be1ed3e8ec3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 16, 2012

Manufacturers
FDA

Dispensing Solutions, Inc.

DUNS: 066070785

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 Code68258-6010
Application NumberANDA078955
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propranolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2012
FDA Product Classification

INGREDIENTS (7)

FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: F8A3652H1V
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT

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Propranolol Hydrochloride - FDA Drug Approval Details