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
1e1dfacf-b831-4743-a874-9a5e5ef8a120
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2021
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 Code76282-671
Application NumberANDA077900
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ramipril
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2021
FDA Product Classification
INGREDIENTS (10)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
RAMIPRILActive
Quantity: 2.5 mg in 1 1
Code: L35JN3I7SJ
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Ramipril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-672
Application NumberANDA077900
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ramipril
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2021
FDA Product Classification
INGREDIENTS (12)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
RAMIPRILActive
Quantity: 5 mg in 1 1
Code: L35JN3I7SJ
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Ramipril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-670
Application NumberANDA077900
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ramipril
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2021
FDA Product Classification
INGREDIENTS (11)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
RAMIPRILActive
Quantity: 1.25 mg in 1 1
Code: L35JN3I7SJ
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Ramipril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-673
Application NumberANDA077900
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ramipril
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2021
FDA Product Classification
INGREDIENTS (12)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
RAMIPRILActive
Quantity: 10 mg in 1 1
Code: L35JN3I7SJ
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT