RAMIPRIL- ramipril capsule, gelatin coated 
DIRECT RX

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RAMIPRIL 10mg

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

13 NONCLINICAL TOXICOLOGY

14 CLINICAL STUDIES

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

Ramipril 10mg

RAMIPRIL 
ramipril capsule, gelatin coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-833(NDC:65862-477)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G) RAMIPRIL10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
GELATIN (UNII: 2G86QN327L)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SHELLAC (UNII: 46N107B71O)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code D;08
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-833-3030 in 1 BOTTLE; Type 0: Not a Combination Product02/04/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09160401/13/2016
Labeler - DIRECT RX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DIRECT RX079254320repack(61919-833)

Revised: 2/2016
Document Id: 2b5cc18d-4342-40dd-e054-00144ff88e88
Set id: 2b5cc18d-4341-40dd-e054-00144ff88e88
Version: 1
Effective Time: 20160209
 
DIRECT RX