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 USP Initial U.S. Approval: 1991
Approved
Approval ID
2a8bc721-1404-4cf3-821b-8a7db2021432
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
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 Code63187-644
Application NumberANDA202392
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ramipril
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2018
FDA Product Classification
INGREDIENTS (9)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
RAMIPRILActive
Quantity: 2.5 mg in 1 1
Code: L35JN3I7SJ
Classification: ACTIB
SHELLACInactive
Code: 46N107B71O
Classification: IACT