Ramipril
These highlights do not include all the information needed to use ramipril capsules safely and effectively. See full prescribing information for ramipril capsules.
Approved
Approval ID
9d008401-4746-4dc5-94ab-4462f959fb73
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 25, 2013
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5843
Application NumberANDA076549
Product Classification
M
Marketing Category
C73584
G
Generic Name
ramipril
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2013
FDA Product Classification
INGREDIENTS (8)
RAMIPRILActive
Quantity: 10 mg in 1 1
Code: L35JN3I7SJ
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ramipril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5856
Application NumberANDA076549
Product Classification
M
Marketing Category
C73584
G
Generic Name
ramipril
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2013
FDA Product Classification
INGREDIENTS (8)
RAMIPRILActive
Quantity: 2.5 mg in 1 1
Code: L35JN3I7SJ
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ramipril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5896
Application NumberANDA076549
Product Classification
M
Marketing Category
C73584
G
Generic Name
ramipril
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2013
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
RAMIPRILActive
Quantity: 1.25 mg in 1 1
Code: L35JN3I7SJ
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ramipril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5842
Application NumberANDA076549
Product Classification
M
Marketing Category
C73584
G
Generic Name
ramipril
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2013
FDA Product Classification
INGREDIENTS (8)
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
RAMIPRILActive
Quantity: 5 mg in 1 1
Code: L35JN3I7SJ
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT