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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

85019b67-a5de-c395-e053-2991aa0a9a7b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 26, 2019

Manufacturers
FDA

St. Mary's Medical Park Pharmacy

DUNS: 063050751

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 Code60760-571
Application NumberANDA091604
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ramipril
Product Specifications
Route of AdministrationORAL
Effective DateMarch 26, 2019
FDA Product Classification

INGREDIENTS (9)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
RAMIPRILActive
Quantity: 10 mg in 1 1
Code: L35JN3I7SJ
Classification: ACTIB
SHELLACInactive
Code: 46N107B71O
Classification: IACT

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Ramipril - FDA Drug Approval Details