NDC Code(s) : 42385-972-30, 42385-972-90, 42385-972-01, 42385-972-05, 42385-972-11, 42385-972-72, 42385-973-30, 42385-973-90, 42385-973-01, 42385-973-05, 42385-973-11, 42385-973-72, 42385-974-30, 42385-974-90, 42385-974-01, 42385-974-05, 42385-974-11, 42385-974-72
Packager : Laurus Labs Limited

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Gabapentin Gabapentin CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:42385-972
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN(UNII: 6CW7F3G59X)
(GABAPENTIN - UNII:6CW7F3G59X) 		GABAPENTIN100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
MANNITOL(UNII: 3OWL53L36A)
TALC(UNII: 7SEV7J4R1U)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
SHELLAC(UNII: MB5IUD6JUA)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code LL100
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42385-972-3030 in 1 BOTTLE Type 0: Not a Combination Product13/05/2023
2NDC:42385-972-9090 in 1 BOTTLE Type 0: Not a Combination Product13/05/2023
3NDC:42385-972-01100 in 1 BOTTLE Type 0: Not a Combination Product13/05/2023
4NDC:42385-972-05500 in 1 BOTTLE Type 0: Not a Combination Product13/05/2023
5NDC:42385-972-111000 in 1 BOTTLE Type 0: Not a Combination Product13/05/2023
6NDC:42385-972-7210 in 1 CARTON 13/05/2023
610 in 1 BLISTER PACK Type 0: Not a Combination Product13/05/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217546 05/13/2023
Gabapentin Gabapentin CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:42385-973
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN(UNII: 6CW7F3G59X)
(GABAPENTIN - UNII:6CW7F3G59X) 		GABAPENTIN300 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
MANNITOL(UNII: 3OWL53L36A)
TALC(UNII: 7SEV7J4R1U)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
SHELLAC(UNII: MB5IUD6JUA)
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code LL300
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42385-973-3030 in 1 BOTTLE Type 0: Not a Combination Product13/05/2023
2NDC:42385-973-9090 in 1 BOTTLE Type 0: Not a Combination Product13/05/2023
3NDC:42385-973-01100 in 1 BOTTLE Type 0: Not a Combination Product13/05/2023
4NDC:42385-973-05500 in 1 BOTTLE Type 0: Not a Combination Product13/05/2023
5NDC:42385-973-111000 in 1 BOTTLE Type 0: Not a Combination Product13/05/2023
6NDC:42385-973-7210 in 1 CARTON 13/05/2023
610 in 1 BLISTER PACK Type 0: Not a Combination Product13/05/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217546 05/13/2023
Gabapentin Gabapentin CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:42385-974
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN(UNII: 6CW7F3G59X)
(GABAPENTIN - UNII:6CW7F3G59X) 		GABAPENTIN400 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
MANNITOL(UNII: 3OWL53L36A)
TALC(UNII: 7SEV7J4R1U)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
SHELLAC(UNII: MB5IUD6JUA)
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code LL400
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42385-974-3030 in 1 BOTTLE Type 0: Not a Combination Product13/05/2023
2NDC:42385-974-9090 in 1 BOTTLE Type 0: Not a Combination Product13/05/2023
3NDC:42385-974-01100 in 1 BOTTLE Type 0: Not a Combination Product13/05/2023
4NDC:42385-974-05500 in 1 BOTTLE Type 0: Not a Combination Product13/05/2023
5NDC:42385-974-111000 in 1 BOTTLE Type 0: Not a Combination Product13/05/2023
6NDC:42385-974-7210 in 1 CARTON 13/05/2023
610 in 1 BLISTER PACK Type 0: Not a Combination Product13/05/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217546 05/13/2023

LABELER - Laurus Labs Limited(915075687)

Establishment
Name Address ID/FEI Business Operations
Laurus Labs Limited (VSP2) 650885309 ANALYSIS(42385-972, 42385-973, 42385-974), MANUFACTURE(42385-972, 42385-973, 42385-974)

PRINCIPAL DISPLAY PANEL

NDC 42385-972-30

Gabapentin

Capsules, USP

100 mg

Dispense the enclosed 

Medication Guide to

each patient.

 

30 Capsules                     Rx only

 

LAURUSLABS


figure5


PRINCIPAL DISPLAY PANEL

Rx only                    NDC 42385-972-17

Gabapentin Capsule, USP

100 mg


figure-6



PRINCIPAL DISPLAY PANEL

NDC 42385-972-72

Gabapentin Capsules, USP

100 mg

Dispense the enclosed Medication

Guide to each patient

For institution use only

100 (10 x 10) Unit-Dose Capsules                  Rx Only

LAURUSLABS


figure7

    

PRINCIPAL DISPLAY PANEL

NDC 42385-973-30

Gabapentin

Capsules, USP

300 mg

Dispense the enclosed

Medication Guide to each patient.

 

30 Capsules                     Rx only

 

LAURUSLABS


figure8

PRINCIPAL DISPLAY PANEL

Rx only                    NDC 42385-973-17

Gabapentin Capsule, USP

300 mg

 

figure9

PRINCIPAL DISPLAY PANEL

NDC 42385-973-72

Gabapentin Capsules, USP

300 mg

Dispense the enclosed Medication

Guide to each patient.

For institution use only

100 (10 x 10) Unit-Dose Capsules                  Rx Only

LAURUSLABS


figure10

PRINCIPAL DISPLAY PANEL

NDC 42385-974-30

Gabapentin

Capsules, USP

400 mg

Dispense the enclosed

Medication Guide to each patient.

 

30 Capsules                     Rx only

 

LAURUSLABS


figure11

 

PRINCIPAL DISPLAY PANEL

Rx only                    NDC 42385-974-17

Gabapentin Capsule, USP

400 mg


figure-12

PRINCIPAL DISPLAY PANEL

NDC 42385-974-72

Gabapentin Capsules, USP

400 mg

Dispense the enclosed Medication

Guide to each patient.

For institution use only

100 (10 x 10) Unit-Dose Capsules                  Rx Only

LAURUSLABS


figure13