Label: RAMIPRIL capsule, gelatin coated
- NDC Code(s): 61919-833-30
- Packager: DIRECT RX
- This is a repackaged label.
- Source NDC Code(s): 65862-477
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 9, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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
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INGREDIENTS AND APPEARANCE
RAMIPRIL
ramipril capsule, gelatin coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-833(NDC:65862-477) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G) RAMIPRIL 10 mg Inactive Ingredients Ingredient Name Strength 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 Color blue Score no score Shape CAPSULE Size 15mm Flavor Imprint Code D;08 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-833-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/04/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091604 01/13/2016 Labeler - DIRECT RX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 repack(61919-833)
