Label: GABAPENTIN capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 67296-1638-2, 67296-1638-6 - Packager: RedPharm Drug, Inc.
- This is a repackaged label.
- Source NDC Code(s): 49483-606
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 13, 2021
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INGREDIENTS AND APPEARANCE
GABAPENTIN
gabapentin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-1638(NDC:49483-606) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN 300 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) GELATIN (UNII: 2G86QN327L) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) Product Characteristics Color yellow Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 104 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67296-1638-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2019 2 NDC:67296-1638-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090007 01/01/2019 Labeler - RedPharm Drug, Inc. (828374897) Establishment Name Address ID/FEI Business Operations RedPharm Drug, Inc. 828374897 repack(67296-1638) , relabel(67296-1638)
