NDC Code(s) : 42571-333-60, 42571-333-90, 42571-333-01, 42571-333-05, 42571-334-60, 42571-334-90, 42571-334-01, 42571-334-05
Packager : Micro Labs Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Metformin HydrochlorideMetformin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-333
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
HYPROMELLOSE 2208 (100000 MPA.S)(UNII: VM7F0B23ZI)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POVIDONE K30(UNII: U725QWY32X)
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
HYDROXYPROPYL CELLULOSE (110000 WAMW)(UNII: 5Y0974F5PW)
Product Characteristics
Color blue Score no score
Shape OVAL Size 16 mm
Flavor Imprint Code M500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42571-333-6060 in 1 BOTTLE Type 0: Not a Combination Product03/01/2023
2NDC:42571-333-9090 in 1 BOTTLE Type 0: Not a Combination Product03/01/2023
3NDC:42571-333-01100 in 1 BOTTLE Type 0: Not a Combination Product03/01/2023
4NDC:42571-333-05500 in 1 BOTTLE Type 0: Not a Combination Product03/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212448 03/01/2023
Metformin HydrochlorideMetformin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-334
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE1000 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K30(UNII: U725QWY32X)
HYPROMELLOSE 2208 (100000 MPA.S)(UNII: VM7F0B23ZI)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
HYDROXYPROPYL CELLULOSE (110000 WAMW)(UNII: 5Y0974F5PW)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL Size 20 mm
Flavor Imprint Code M1000
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42571-334-6060 in 1 BOTTLE Type 0: Not a Combination Product03/01/2023
2NDC:42571-334-9090 in 1 BOTTLE Type 0: Not a Combination Product03/01/2023
3NDC:42571-334-01100 in 1 BOTTLE Type 0: Not a Combination Product03/01/2023
4NDC:42571-334-05500 in 1 BOTTLE Type 0: Not a Combination Product03/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212448 03/01/2023

LABELER - Micro Labs Limited(862174955)

Establishment
Name Address ID/FEI Business Operations
Micro Labs Limited 915793658 analysis(42571-333, 42571-334), label(42571-333, 42571-334), manufacture(42571-333, 42571-334), pack(42571-333, 42571-334)

PRINCIPAL DISPLAY PANEL

NDC 42571-333-01
Metformin
Hydrochloride
Extended-Release
Tablets, USP 
500 mg
Rx Only
Once Daily
100 Tablets
Micro Labs Limited

labl-a

NDC 42571-334-90
Metformin
Hydrochloride
Extended-Release
Tablets, USP 
1,000 mg
Rx Only
Once Daily
90 Tablets
Micro Labs Limited

labl-a