GABAPENTIN capsule

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Direct_Rx

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Bidhaa muhtasari:

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

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

Direct_Rx
----------
Revised: 5/2023
Document Id: fb591a28-d72a-377e-e053-6394a90a2903
34391-3
Set id: 907853a0-9979-62e7-e053-2995a90a5aca
Version: 3
Effective Time: 20230510
Direct_Rx

Tabia za bidhaa

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 TYPE
HUMAN PRESCRIPTION
DRUG
ITEM CODE
(SOURCE)
NDC:61919-640(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
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
GELATIN (UNII: 2G86QN327L)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
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:61919-640-
90
90 in 1 BOTTLE; Type 0: Not a Combination
Product
08/19/2019
2
NDC:61919-640-
82
180 in 1 BOTTLE; Type 0: Not a Combination
Product
08/19/2019
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA090007
08/19/2019
LABELER -
Direct_Rx (079254320)
REGISTRANT -
Direct_Rx (079254320)
Direct_Rx
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Direct_Rx
079254320
repack(61919-640)
Revised: 5/2023