Norpace
Norpace disopyramide phosphate capsules Norpace CR disopyramide phosphate extended-release capsules
Approved
Approval ID
e2aa1642-d262-4520-bc6a-9fd3ad795677
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 30, 2023
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Products 4
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 Code0025-2762
Application NumberNDA017447
Product Classification
M
Marketing Category
C73594
G
Generic Name
disopyramide phosphate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (9)
DISOPYRAMIDE PHOSPHATEActive
Quantity: 150 mg in 1 1
Code: N6BOM1935W
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
disopyramide phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0025-2752
Application NumberNDA017447
Product Classification
M
Marketing Category
C73594
G
Generic Name
disopyramide phosphate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (8)
DISOPYRAMIDE PHOSPHATEActive
Quantity: 100 mg in 1 1
Code: N6BOM1935W
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
disopyramide phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0025-2732
Application NumberNDA018655
Product Classification
M
Marketing Category
C73594
G
Generic Name
disopyramide phosphate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (10)
DISOPYRAMIDE PHOSPHATEActive
Quantity: 100 mg in 1 1
Code: N6BOM1935W
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
disopyramide phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0025-2742
Application NumberNDA018655
Product Classification
M
Marketing Category
C73594
G
Generic Name
disopyramide phosphate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (12)
DISOPYRAMIDE PHOSPHATEActive
Quantity: 150 mg in 1 1
Code: N6BOM1935W
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT