GABAPENTIN capsule

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)

Disponible depuis:

NuCare Pharmaceuticals,Inc.

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

Descriptif du produit:

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

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

NuCare Pharmaceuticals,Inc.
----------
Revised: 2/2021
Document Id: bbb33d86-a7ae-a3a4-e053-2a95a90a18df
34391-3
Set id: 8f785189-bf66-36cc-e053-2a95a90a7cbc
Version: 2
Effective Time: 20210219
NuCare Pharmaceuticals,Inc.

Résumé des caractéristiques du produit

GABAPENTIN- GABAPENTIN CAPSULE
NUCARE PHARMACEUTICALS,INC.
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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 68071-5017-1 BOTTLES OF 100
100 MG GABAPENTIN CAPSULE PACKAGE LABELS
GABAPENTIN
gabapentin capsule
PRODUCT 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
NuCare Pharmaceuticals,Inc.
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)
Revised: 2/2021