NDC Code(s) : 42385-977-30, 42385-977-90, 42385-977-01, 42385-977-18, 42385-977-05, 42385-977-11, 42385-977-72, 42385-978-30, 42385-978-90, 42385-978-01, 42385-978-18, 42385-978-05, 42385-978-11, 42385-978-72
Packager : Laurus Labs Limited

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:42385-977
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE500 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
HYPROMELLOSE 2208 (100000 MPA.S)(UNII: VM7F0B23ZI)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (white to off-white color) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code LA20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42385-977-3030 in 1 BOTTLE Type 0: Not a Combination Product10/06/2023
2NDC:42385-977-9090 in 1 BOTTLE Type 0: Not a Combination Product10/06/2023
3NDC:42385-977-01100 in 1 BOTTLE Type 0: Not a Combination Product10/06/2023
4NDC:42385-977-18180 in 1 BOTTLE Type 0: Not a Combination Product10/06/2023
5NDC:42385-977-05500 in 1 BOTTLE Type 0: Not a Combination Product10/06/2023
6NDC:42385-977-111000 in 1 BOTTLE Type 0: Not a Combination Product10/06/2023
7NDC:42385-977-7215 in 1 CARTON 10/06/2023
710 in 1 BLISTER PACK Type 0: Not a Combination Product10/06/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217631 10/06/2023
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:42385-978
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE750 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
HYPROMELLOSE 2208 (100000 MPA.S)(UNII: VM7F0B23ZI)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (white to off-white color) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code LA19
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42385-978-3030 in 1 BOTTLE Type 0: Not a Combination Product10/06/2023
2NDC:42385-978-9090 in 1 BOTTLE Type 0: Not a Combination Product10/06/2023
3NDC:42385-978-01100 in 1 BOTTLE Type 0: Not a Combination Product10/06/2023
4NDC:42385-978-18180 in 1 BOTTLE Type 0: Not a Combination Product10/06/2023
5NDC:42385-978-05500 in 1 BOTTLE Type 0: Not a Combination Product10/06/2023
6NDC:42385-978-111000 in 1 BOTTLE Type 0: Not a Combination Product10/06/2023
7NDC:42385-978-7215 in 1 CARTON 10/06/2023
710 in 1 BLISTER PACK Type 0: Not a Combination Product10/06/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217631 10/06/2023

LABELER - Laurus Labs Limited(915075687)

Establishment
Name Address ID/FEI Business Operations
Laurus Labs Limited (VSP2) 650885309 ANALYSIS(42385-977, 42385-978), API MANUFACTURE(42385-977, 42385-978), MANUFACTURE(42385-977, 42385-978)

PRINCIPAL DISPLAY PANEL

NDC 42385-977-30

Metformin Hydrochloride

Extended-Release

Tablets, USP

500 mg

   

30 Tablets                     Rx Only

 

LAURUS Labs

fig-1

PRINCIPAL DISPLAY PANEL

Rx Only                    NDC 42385-977-17

Metformin Hydrochloride

Extended-Release Tablets,

USP

500 mg

fig-2

PRINCIPAL DISPLAY PANEL

NDC 42385-977-72

Metformin Hydrochloride

Extended-Release Tablets, USP

500 mg

For in-institution use only

150 (15 x 10) Unit-Dose Tablets                  Rx Only

LAURUS Labs

fig-3

PRINCIPAL DISPLAY PANEL

NDC 42385-978-30

Metformin Hydrochloride

Extended-Release

Tablets, USP

750 mg

30 Tablets                            Rx Only


LAURUS Labs


fig-4

PRINCIPAL DISPLAY PANEL

Rx Only                    NDC 42385-978-17

Metformin Hydrochloride

Extended-Release Tablet,

USP

750 mg

fig-5

PRINCIPAL DISPLAY PANEL

NDC 42385-978-72

Metformin Hydrochloride

Extended-Release Tablets, USP

750 mg

150 (15 x 10) Unit-Dose Tablets                  Rx Only

LAURUS Labs

fig-6