Ramipril
These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES.RAMIPRIL capsules, for oral useInitial U.S. Approval: 1991
Approved
Approval ID
2e6303e8-1c22-451f-8733-a55e237ff961
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2017
Manufacturers
FDA
Exelan Pharmaceuticals, Inc.
DUNS: 967795266
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ramipril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-274
Application NumberANDA078745
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ramipril
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2016
FDA Product Classification
INGREDIENTS (8)
RAMIPRILActive
Quantity: 10 mg in 1 1
Code: L35JN3I7SJ
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Ramipril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-273
Application NumberANDA078745
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ramipril
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2016
FDA Product Classification
INGREDIENTS (10)
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
RAMIPRILActive
Quantity: 5 mg in 1 1
Code: L35JN3I7SJ
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Ramipril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-272
Application NumberANDA078745
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ramipril
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2016
FDA Product Classification
INGREDIENTS (9)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
RAMIPRILActive
Quantity: 2.5 mg in 1 1
Code: L35JN3I7SJ
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Ramipril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-271
Application NumberANDA078745
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ramipril
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2016
FDA Product Classification
INGREDIENTS (8)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
RAMIPRILActive
Quantity: 1.25 mg in 1 1
Code: L35JN3I7SJ
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT