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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
Effective Date
July 6, 2017
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ramipril(1.25 mg in 1 1)

Manufacturing Establishments1

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

Carilion Materials Management

Carilion Materials Management

079239644

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
68151-0681
Application Number
ANDA077900
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 6, 2016
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
RamiprilActive
Code: L35JN3I7SJClass: ACTIBQuantity: 1.25 mg in 1 1
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
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Ramipril - FDA Approval | MedPath