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FDA Approval

Ramipril

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Proficient Rx LP
DUNS: 079196022
Effective Date
November 1, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ramipril(2.5 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Proficient Rx LP

Proficient Rx LP

079196022

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ramipril

Product Details

NDC Product Code
63187-644
Application Number
ANDA202392
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 1, 2018
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
RamiprilActive
Code: L35JN3I7SJClass: ACTIBQuantity: 2.5 mg in 1 1
SHELLACInactive
Code: 46N107B71OClass: IACT
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