Label: GABAPENTIN capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 51655-379-25, 51655-379-26, 51655-379-52 - Packager: Northwind Pharmaceuticals
- 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 June 20, 2018
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- HOW SUPPLIED
- MedGuide Section
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300mg Gabapentin Capsule Package Label
NDC: 51655-379-25
MFG: 49483-606-50
Gabapentin 300mg
60 Capsules
Rx Only
Lot #:
Exp.Date:
Each capsule contains:
Gabapentin,USP....300mg
Dosage: See prescriber's instructions.
Store between 59 to 86 degrees F.
Store in this tight, light-resistant container. Protect from moisture. Keep this out of the reach of children.
Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729
Mfg by: Marksans Pharma Ltd. Verna Indl. Estate, Verna, Goa-403 722, India
Distributed by: Time-Cap Labs, Inc. 7 Michael Ave. Farmingdale, NY 11735 Lot#
Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256
NDC: 51655-379-52
MFG: 49483-606-50
Gabapentin 300mg
30 Capsules
Rx Only
Lot #:
Exp.Date:
Each capsule contains:
Gabapentin,USP....300mg
Dosage: See prescriber's instructions.
Store between 59 to 86 degrees F.
Store in this tight, light-resistant container. Protect from moisture. Keep this out of the reach of children.
Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729
Mfg by: Marksans Pharma Ltd. Verna Indl. Estate, Verna, Goa-403 722, India
Distributed by: Time-Cap Labs, Inc. 7 Michael Ave. Farmingdale, NY 11735 Lot#
Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256
NDC: 51655-379-26
MFG: 49483-606-50
Gabapentin 300mg
90 Capsules
Rx Only
Lot #:
Exp.Date:
Each capsule contains:
Gabapentin,USP....300mg
Dosage: See prescriber's instructions.
Store between 59 to 86 degrees F.
Store in this tight, light-resistant container. Protect from moisture. Keep this out of the reach of children.
Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729
Mfg by: Marksans Pharma Ltd. Verna Indl. Estate, Verna, Goa-403 722, India
Distributed by: Time-Cap Labs, Inc. 7 Michael Ave. Farmingdale, NY 11735 Lot#
Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256
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INGREDIENTS AND APPEARANCE
GABAPENTIN
gabapentin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-379(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 LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) 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:51655-379-25 60 in 1 BOTTLE; Type 0: Not a Combination Product 06/20/2018 2 NDC:51655-379-52 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/02/2018 3 NDC:51655-379-26 90 in 1 CAPSULE; Type 0: Not a Combination Product 10/04/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090007 06/20/2018 Labeler - Northwind Pharmaceuticals (036986393) Registrant - Northwind Pharmaceuticals (036986393) Establishment Name Address ID/FEI Business Operations Northwind Pharmaceuticals 036986393 relabel(51655-379)
