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 use Initial U.S. Approval: 1991
Approved
Approval ID
e4144b15-406d-4169-9ca7-12a6fce38263
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 14, 2021
Manufacturers
FDA
Accord Healthcare Inc.
DUNS: 604222237
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 Code16729-155
Application NumberANDA202392
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ramipril
Product Specifications
Route of AdministrationORAL
Effective DateMay 14, 2021
FDA Product Classification
INGREDIENTS (8)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
RAMIPRILActive
Quantity: 10 mg in 1 1
Code: L35JN3I7SJ
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Ramipril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-154
Application NumberANDA202392
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ramipril
Product Specifications
Route of AdministrationORAL
Effective DateMay 14, 2021
FDA Product Classification
INGREDIENTS (9)
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
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
Ramipril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-153
Application NumberANDA202392
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ramipril
Product Specifications
Route of AdministrationORAL
Effective DateMay 14, 2021
FDA Product Classification
INGREDIENTS (9)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
RAMIPRILActive
Quantity: 2.5 mg in 1 1
Code: L35JN3I7SJ
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Ramipril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-152
Application NumberANDA202392
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ramipril
Product Specifications
Route of AdministrationORAL
Effective DateMay 14, 2021
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
RAMIPRILActive
Quantity: 1.25 mg in 1 1
Code: L35JN3I7SJ
Classification: ACTIB