Prescription Drug Information: Gabapentin (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gabapentin Capsules USP, 100 mg

PHARMACIST: Please dispense the accompanying Medication Guide to each patient.

Rx Only

30 Capsules

image
(click image for full-size original)

Gabapentin Capsules USP, 300 mg

PHARMACIST: Please dispense the accompanying Medication Guide to each patient.

Rx Only

30 Capsules

image
(click image for full-size original)

Gabapentin Capsules USP, 400 mg

PHARMACIST: Please dispense the accompanying Medication Guide to each patient.

Rx Only

30 Capsules

image
(click image for full-size original)
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-055
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
MAGNESIUM STEARATE
TITANIUM DIOXIDE
GELATIN
SHELLAC
DEHYDRATED ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FD&C BLUE NO. 1 ALUMINUM LAKE
ISOPROPYL ALCOHOL
Product Characteristics
Color WHITE (White opaque cap and White opaque body) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 100mg;236
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69844-055-01 30 CAPSULE in 1 BOTTLE None
2 NDC:69844-055-02 100 CAPSULE in 1 BOTTLE None
3 NDC:69844-055-03 1000 CAPSULE in 1 BOTTLE None
4 NDC:69844-055-04 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207099 03/24/2017
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-056
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
MAGNESIUM STEARATE
TITANIUM DIOXIDE
GELATIN
SHELLAC
DEHYDRATED ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FD&C BLUE NO. 1 ALUMINUM LAKE
ISOPROPYL ALCOHOL
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW (Yellow opaque cap and Yellow opaque body) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 300mg;235
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69844-056-01 30 CAPSULE in 1 BOTTLE None
2 NDC:69844-056-02 100 CAPSULE in 1 BOTTLE None
3 NDC:69844-056-03 1000 CAPSULE in 1 BOTTLE None
4 NDC:69844-056-04 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207099 03/24/2017
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-057
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
MAGNESIUM STEARATE
TITANIUM DIOXIDE
GELATIN
SHELLAC
DEHYDRATED ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FD&C BLUE NO. 1 ALUMINUM LAKE
ISOPROPYL ALCOHOL
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color ORANGE (Orange opaque cap and Orange opaque body) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code 400mg;234
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69844-057-01 30 CAPSULE in 1 BOTTLE None
2 NDC:69844-057-02 100 CAPSULE in 1 BOTTLE None
3 NDC:69844-057-03 1000 CAPSULE in 1 BOTTLE None
4 NDC:69844-057-04 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207099 03/24/2017
Labeler — Graviti Pharmaceuticals Private Limited (650884781)
Registrant — Graviti Pharmaceuticals Private Limited (650884781)
Establishment
Name Address ID/FEI Operations
Graviti Pharmaceuticals Private Limited 650884781 MANUFACTURE (69844-055), MANUFACTURE (69844-056), MANUFACTURE (69844-057), ANALYSIS (69844-055), ANALYSIS (69844-056), ANALYSIS (69844-057)
Establishment
Name Address ID/FEI Operations
Wuhan Humanwell Likang Pharmaceutical Co., Ltd. 539959491 MANUFACTURE (69844-055), MANUFACTURE (69844-056), MANUFACTURE (69844-057)

Revised: 01/2023 Graviti Pharmaceuticals Private Limited

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