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:
Direct_Rx
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) 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
Authorization status:
Abbreviated New Drug Application
Authorization number:
61919-640-60

Direct_Rx

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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

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

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