GABAPENTIN by Northwind Pharmaceuticals GABAPENTIN capsule

GABAPENTIN by

Drug Labeling and Warnings

GABAPENTIN by is a Prescription medication manufactured, distributed, or labeled by Northwind Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HOW SUPPLIED

300 mg Capsules (Yellow/Yellow colored, size '1' hard gelatin capsules with "104" printed on body of capsules containing white to off white granular powder) Bottles of 30, 60 and 90 Capsules.

MedGuide Section

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

INGREDIENTS AND APPEARANCE

GABAPENTIN 
gabapentin capsule

Product 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)