GABAPENTIN capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Direct_Rx

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Каталог на резюме:

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) Bottles of 100 & 500 300 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 100 & 500 400 mg Capsules (Orange/Orange colored, size '0' hard gelatin capsules with "105" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500

Статус Оторизация:

Abbreviated New Drug Application

Листовка

Direct_Rx
----------
Revised: 8/2019
Document Id: 8f9fc8a2-0d11-12f1-e053-2995a90acf3d
34391-3
Set id: 8f9fc8a2-0d10-12f1-e053-2995a90acf3d
Version: 1
Effective Time: 20190808
Direct_Rx

Данни за продукта

GABAPENTIN- GABAPENTIN CAPSULE
DIRECT_RX
----------
GABAPENTIN
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) Bottles of 100
& 500
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 100
& 500
400 mg Capsules (Orange/Orange colored, size '0' hard gelatin capsules
with "105" printed on body of
capsules containing white to off white granular powder) Bottles of 100
& 500
GABAPENTIN
gabapentin capsule
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:6 19 19 -6 40 (NDC:49 48 3-6 0 6 )
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
30 0 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
SHELLAC (UNII: 46 N10 7B71O)
LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)
STARCH, CO RN (UNII: O8 232NY3SJ)
Dire ct_Rx
TALC (UNII: 7SEV7J4R1U)
FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)
GELATIN (UNII: 2G8 6 QN327L)
PRODUCT CHARACTERISTICS
COLOR
ye llo w
S CORE
no sco re
S HAP E
CAPSULE
S IZ E
19 mm
FLAVOR
IMPRINT CODE
10 4
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 19 19 -6 40 -6 0
6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
0 8 /0 8 /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
0 8 /0 8 /20 19
LABELER -
Direct_Rx (079254320)
REGISTRANT -
Direct_Rx (079254320)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Dire c t_Rx
0 79 254320
re pa c k(6 19 19 -6 40 )
Revised: 8/2019