Label: GABAPENTIN capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 71610-195-60, 71610-195-92 - Packager: Aphena Pharma Solutions - Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 49483-607
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 1, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Medication Guide: HTML
- Official Label (Printer Friendly)
- HOW SUPPLIED
- HOW SUPPLIED
- HOW SUPPLIED
- MEDICATION GUIDE
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Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
Count 400 mg 90 71610-195-60 270 71610-195-92 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20190801JH - PRINCIPAL DISPLAY PANEL - 400 mg
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INGREDIENTS AND APPEARANCE
GABAPENTIN
gabapentin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71610-195(NDC:49483-607) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN 400 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) GELATIN (UNII: 2G86QN327L) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) Product Characteristics Color orange Score no score Shape CAPSULE Size 21mm Flavor Imprint Code 105 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71610-195-60 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/16/2018 2 NDC:71610-195-92 270 in 1 BOTTLE; Type 0: Not a Combination Product 11/16/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090007 12/30/2015 Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK(71610-195)
