Gabapentin (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gabapentin Capsules USP, 100 mg

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

Rx Only

30 Capsules

Gabapentin Capsules USP, 300 mg

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

Rx Only

30 Capsules

Gabapentin Capsules USP, 400 mg

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

Rx Only

30 Capsules

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