GABAPENTIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]

GABAPENTIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]
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NDC	68071-4784-1
Set ID	82c0ed15-9132-657d-e053-2991aa0ae90a
Category	HUMAN PRESCRIPTION DRUG LABEL
Packager	NuCare Pharmaceuticals,Inc.
Generic Name
Product Class	Anti-epileptic Agent
Product Number
Application Number	ANDA090007

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HOW SUPPLIED

100 mg Capsules (White/White colored, size 3 hard gelatin capsules with 103 printed on body of capsules containing white to off white granular powder)

NDC 68071-4784-1 BOTTLES OF 100
MEDICATION GUIDE
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GABAPENTIN
gabapentin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:68071-4784(NDC:49483-606)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)	GABAPENTIN	300 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68071-4784-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/25/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090007	12/30/2015

Labeler - NuCare Pharmaceuticals,Inc. (010632300)

Name	Address	ID/FEI	Business Operations
Establishment
NuCare Pharmaceuticals,Inc.		010632300	relabel(68071-4784)

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