Label: GABAPENTIN capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 68071-5017-1 - Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 49483-605
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 19, 2021
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- HOW SUPPLIED
- MEDICATION GUIDE
- 100 mg Gabapentin Capsule Package Labels
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INGREDIENTS AND APPEARANCE
GABAPENTIN
gabapentin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-5017(NDC:49483-605) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN 100 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) GELATIN (UNII: 2G86QN327L) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) Product Characteristics Color white Score no score Shape CAPSULE Size 16mm Flavor Imprint Code 103 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-5017-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/06/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090007 12/30/2015 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-5017)
