GABAPENTIN- gabapentin capsule

United States - English - NLM (National Library of Medicine)

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Active ingredient:
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
Available from:
NuCare Pharmaceuticals,Inc.
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Product summary:
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 68071-5017-1 BOTTLES OF 100
Authorization status:
Abbreviated New Drug Application
Authorization number:
68071-5017-1

NuCare Pharmaceuticals,Inc.

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Revised: 8/2019

Document Id: 8f7843d6-abf8-6a58-e053-2995a90ab69e

34391-3

Set id: 8f785189-bf66-36cc-e053-2a95a90a7cbc

Version: 1

Effective Time: 20190806

NuCare Pharmaceuticals,Inc.

GABAPENTIN- gabapentin capsule

NuCare Pharmaceuticals,Inc.

----------

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 68071-5017-1 BOTTLES OF 100

100 mg Gabapentin Capsule Package Labels

GABAPENTIN

gabapentin capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 8 0 71-50 17(NDC:49 48 3-6 0 5)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

GABAPENTIN (UNII: 6 CW7F3G59 X) (GABAPENTIN - UNII:6 CW7F3G59 X)

GABAPENTIN

10 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

STARCH, CO RN (UNII: O8 232NY3SJ)

TALC (UNII: 7SEV7J4R1U)

GELATIN (UNII: 2G8 6 QN327L)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SHELLAC (UNII: 46 N10 7B71O)

Product Characteristics

Color

white

S core

no sco re

S hap e

CAPSULE

S iz e

16 mm

Flavor

Imprint Code

10 3

Contains

NuCare Pharmaceuticals,Inc.

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 0 71-50 17-1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 6 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 0 0 0 7

12/30 /20 15

Labeler -

NuCare Pharmaceuticals,Inc. (010632300)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

NuCare Pharmaceuticals,Inc.

0 10 6 3230 0

re la be l(6 8 0 71-50 17)

Revised: 8/2019

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