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Norpace

Norpace disopyramide phosphate capsules Norpace CR disopyramide phosphate extended-release capsules

Approved
Approval ID

4c02f1b8-4493-429c-b9f7-21f364e330f8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 24, 2010

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

disopyramide phosphate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68151-0526
Application NumberNDA018655
Product Classification
M
Marketing Category
C73594
G
Generic Name
disopyramide phosphate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2010
FDA Product Classification

INGREDIENTS (6)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
disopyramide phosphateActive
Quantity: 100 mg in 1 1
Code: N6BOM1935W
Classification: ACTIM

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Norpace - FDA Drug Approval Details