Gabapentin (Page 8 of 8)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 100 mg (100 Capsules Bottle)

NDC 65862-199-01
Gabapentin Capsules, USP
300 mg
PHARMACIST: Dispense the Medication
Guide provided separately to each patient.
Rx only 100 Capsules AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 300 mg (100 Capsule Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 100 mg Blister Carton 10 (1 x 10 Unit-dose)

NDC 65862-198-10
Rx only
Gabapentin Capsules, USP
100 mg
PHARMACIST: Dispense the Medication Guide
provided separately to each patient. AUROBINDO 10 (1 X10) Unit-dose Capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 100 mg Blister Carton 10 (1 x 10 Unit-dose)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 300 mg (100 Capsules Bottle)

NDC 65862-199-01
Rx only
Gabapentin Capsules, USP
300 mg
PHARMACIST: Dispense the Medication Guide
provided separately to each patient.
AUROBINDO 100 Capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 300 mg (100 Capsules Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 300 mg Blister Carton 10 (1 x 10 Unit-dose)

NDC 65862-199-10
Rx only
Gabapentin Capsules, USP
300 mg
PHARMACIST: Dispense the Medication Guide
provided separately to each patient.
AUROBINDO 10 (1 X10) Unit-dose Capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 300 mg Blister Carton 10 (1 x 10 Unit-dose)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 400 mg (100 Capsules Bottle)

NDC 65862-200-01
Rx only
Gabapentin Capsules, USP
400 mg
PHARMACIST: Dispense the Medication Guide
provided separately to each patient.
AUROBINDO 100 Capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 400 mg (100 Capsules Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 400 mg Blister Carton 10 (1 x 10 Unit-dose)

NDC 65862-200-10
Rx only
Gabapentin Capsules, USP
400 mg
PHARMACIST: Dispense the Medication Guide
provided separately to each patient.
AUROBINDO 10 (1 X10) Unit-dose Capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 400 mg Blister Carton 10 (1 x 10 Unit-dose)
(click image for full-size original)

GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-198
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
TALC
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
SHELLAC
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code D;02
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-198-01 100 CAPSULE in 1 BOTTLE None
2 NDC:65862-198-05 500 CAPSULE in 1 BOTTLE None
3 NDC:65862-198-99 1000 CAPSULE in 1 BOTTLE None
4 NDC:65862-198-10 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (65862-198-10)
5 NDC:65862-198-90 90 CAPSULE in 1 BOTTLE None
6 NDC:65862-198-18 180 CAPSULE in 1 BOTTLE None
7 NDC:65862-198-27 270 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078787 01/31/2008
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-199
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 300 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
TALC
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
SHELLAC
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code D;03
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-199-01 100 CAPSULE in 1 BOTTLE None
2 NDC:65862-199-05 500 CAPSULE in 1 BOTTLE None
3 NDC:65862-199-99 1000 CAPSULE in 1 BOTTLE None
4 NDC:65862-199-10 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (65862-199-10)
5 NDC:65862-199-30 30 CAPSULE in 1 BOTTLE None
6 NDC:65862-199-60 60 CAPSULE in 1 BOTTLE None
7 NDC:65862-199-90 90 CAPSULE in 1 BOTTLE None
8 NDC:65862-199-18 180 CAPSULE in 1 BOTTLE None
9 NDC:65862-199-27 270 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078787 01/31/2008
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-200
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 400 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
TALC
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
SHELLAC
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code D;04
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-200-01 100 CAPSULE in 1 BOTTLE None
2 NDC:65862-200-05 500 CAPSULE in 1 BOTTLE None
3 NDC:65862-200-10 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (65862-200-10)
4 NDC:65862-200-90 90 CAPSULE in 1 BOTTLE None
5 NDC:65862-200-27 270 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078787 01/31/2008
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurolife Pharma LLC 829084461 ANALYSIS (65862-198), ANALYSIS (65862-199), ANALYSIS (65862-200), MANUFACTURE (65862-198), MANUFACTURE (65862-199), MANUFACTURE (65862-200)
Establishment
Name Address ID/FEI Operations
Aurolife Pharma LLC 078296263 RELABEL (65862-198), RELABEL (65862-199), RELABEL (65862-200), REPACK (65862-198), REPACK (65862-199), REPACK (65862-200), LABEL (65862-198), LABEL (65862-199), LABEL (65862-200), PACK (65862-198), PACK (65862-199), PACK (65862-200)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 ANALYSIS (65862-198), ANALYSIS (65862-199), ANALYSIS (65862-200), MANUFACTURE (65862-198), MANUFACTURE (65862-199), MANUFACTURE (65862-200)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-198), ANALYSIS (65862-199), ANALYSIS (65862-200), MANUFACTURE (65862-198), MANUFACTURE (65862-199), MANUFACTURE (65862-200)

Revised: 10/2021 Aurobindo Pharma Limited

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