Gabapentin (Page 9 of 9)

Gabapentin 100mg, 300mg and 400mg container label.

100mg-100cc
(click image for full-size original)
100mg-500cc
(click image for full-size original)
300mg-100cc
(click image for full-size original)
300mg-500cc
(click image for full-size original)
400mg-100cc
(click image for full-size original)
400mg-500cc
(click image for full-size original)
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71093-120
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
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
ALCOHOL
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
SHELLAC
PROPYLENE GLYCOL
AMMONIA
Product Characteristics
Color WHITE (Opaque Body and Opaque Cap) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code AHD;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71093-120-04 100 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:71093-120-05 500 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206943 05/14/2018
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71093-121
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
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
ALCOHOL
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
SHELLAC
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
PROPYLENE GLYCOL
AMMONIA
Product Characteristics
Color YELLOW (Yellow Body) , BROWN (Caramel Cap) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code AHD;300
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71093-121-04 100 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:71093-121-05 500 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206943 05/14/2018
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71093-122
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
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
ALCOHOL
ISOPROPYL ALCOHOL
SHELLAC
POTASSIUM HYDROXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
PROPYLENE GLYCOL
AMMONIA
Product Characteristics
Color ORANGE (Orange Body) , BROWN (Caramel Cap) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code AHD;400
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71093-122-04 100 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:71093-122-05 500 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206943 05/14/2018
Labeler — ACI Healthcare USA, Inc. (080430318)
Registrant — ACI HealthCare Limited (731584418)
Establishment
Name Address ID/FEI Operations
Strides Pharma Science Limited 871402375 manufacture (71093-120), pack (71093-120), manufacture (71093-121), pack (71093-121), manufacture (71093-122), pack (71093-122)
Establishment
Name Address ID/FEI Operations
Vivimed Life Sciences Private Limited 860477684 manufacture (71093-120), pack (71093-120), manufacture (71093-121), pack (71093-121), manufacture (71093-122), pack (71093-122)

Revised: 04/2021 ACI Healthcare USA, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.