Label: GABAPENTIN capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 69512-102-10 - Packager: Alivio Medical Products, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 14, 2015
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DESCRIPTION
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- PRECAUTIONS
- SUMMARY OF SAFETY AND EFFECTIVENESS
- SPL UNCLASSIFIED SECTION
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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DOSAGE FORMS & STRENGTHS
DOSAGE FORMS AND STRENGTHS
Capsules:
- 100 mg; white-white, opague hard gelatin capsules printed with "IP 101 " on both cap and body.
- 300 mg: buff-buff, opague hard gelatin capsules printed with "IP 102" on both cap and body.
- 400 mg: light caramel-light caramel, opague hard gelatin capsules printed with "IP 103" on both cap and body
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- DESCRIPTION
- CLINICAL PHARMACOLOGY
- NONCLINICAL TOXICOLOGY
- CLINICAL STUDIES
- HOW SUPPLIED
- PATIENT MEDICATION INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GABAPENTIN
gabapentin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69512-102 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN 300 mg in 300 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color yellow (Yellow (buff buff)) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code IP102 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69512-102-10 100 in 1 BOTTLE 1 300 mg in 1 CAPSULE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078428 10/01/2015 Labeler - Alivio Medical Products, LLC (079670828)