Norpace
Norpace disopyramide phosphate capsules Norpace CR disopyramide phosphate extended-release capsules
Approved
Approval ID
f5e0c230-db38-4476-8357-9a227ccff1bc
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 Code68151-0527
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 (11)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
disopyramide phosphateActive
Quantity: 150 mg in 1 1
Code: N6BOM1935W
Classification: ACTIM
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT