NDC 42385-903

Metformin Hydrochloride

Metformin Hydrochloride

Metformin Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Laurus Labs Limited. The primary component is Metformin Hydrochloride.

• Product ID: 42385-903_2c0747fd-dbaa-4e08-bbcf-317f14eda820
• NDC: 42385-903
• Product Type: Human Prescription Drug
• Proprietary Name: Metformin Hydrochloride
• Generic Name: Metformin Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-01-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209882
• Labeler Name: Laurus Labs Limited
• Substance Name: METFORMIN HYDROCHLORIDE
• Active Ingredient Strength: 850 mg/1
• Pharm Classes: Biguanide [EPC],Biguanides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 42385-903-01

100 TABLET, FILM COATED in 1 BOTTLE (42385-903-01)

• Marketing Start Date: 2019-01-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42385-903-09 [42385090309]

Metformin Hydrochloride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA209882
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-15

NDC 42385-903-10 [42385090310]

Metformin Hydrochloride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA209882
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-15

NDC 42385-903-05 [42385090305]

Metformin Hydrochloride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA209882
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-15

NDC 42385-903-01 [42385090301]

Metformin Hydrochloride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA209882
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-15

Drug Details

Active Ingredients

Ingredient	Strength
METFORMIN HYDROCHLORIDE	850 mg/1

OpenFDA Data

• SPL SET ID: 79e46fdc-6200-4312-a87c-ea9294bf22e0
• Manufacturer:
  • Laurus Labs Limited
• UNII:
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 861007
  • 861010
  • 861004
• UPC Code:
  • 0342385904093
  • 0342385903096
  • 0342385902068

Pharmacological Class

• Biguanide [EPC]
• Biguanides [CS]
• Biguanide [EPC]
• Biguanides [CS]

NDC Crossover Matching brand name "Metformin Hydrochloride" or generic name "Metformin Hydrochloride"

NDC	Brand Name	Generic Name
0093-1048	Metformin Hydrochloride	Metformin Hydrochloride
0093-1049	Metformin Hydrochloride	Metformin Hydrochloride
0093-7212	Metformin Hydrochloride	Metformin Hydrochloride
0093-7214	Metformin Hydrochloride	Metformin Hydrochloride
0093-7267	Metformin Hydrochloride	Metformin Hydrochloride
0179-1979	Metformin Hydrochloride	Metformin Hydrochloride
0185-4416	metformin hydrochloride	metformin hydrochloride
0378-6001	Metformin Hydrochloride	metformin
0378-6002	Metformin Hydrochloride	metformin
0378-7185	Metformin Hydrochloride	metformin hydrochloride
0378-7186	Metformin Hydrochloride	metformin hydrochloride
0378-7187	Metformin Hydrochloride	metformin hydrochloride
0440-5739	Metformin Hydrochloride	Metformin Hydrochloride
0440-5745	Metformin Hydrochloride	Metformin Hydrochloride
0440-5746	Metformin Hydrochloride	Metformin Hydrochloride
0591-2411	Metformin Hydrochloride	Metformin Hydrochloride
0591-2412	Metformin Hydrochloride	Metformin Hydrochloride
0591-2719	Metformin Hydrochloride	Metformin Hydrochloride
0591-2720	Metformin Hydrochloride	Metformin Hydrochloride
0615-5583	Metformin Hydrochloride	Metformin Hydrochloride
0615-7626	Metformin Hydrochloride	Metformin Hydrochloride
0615-7627	Metformin Hydrochloride	Metformin Hydrochloride
0615-7628	Metformin Hydrochloride	Metformin Hydrochloride
0615-7661	Metformin Hydrochloride	Metformin Hydrochloride
0615-7662	Metformin Hydrochloride	Metformin Hydrochloride
0615-7663	Metformin Hydrochloride	Metformin Hydrochloride
0615-7847	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
0615-7982	Metformin Hydrochloride	Metformin Hydrochloride
67877-217	Metformin Hydrochloride	Metformin Hydrochloride
67877-221	Metformin Hydrochloride	Metformin Hydrochloride
67877-218	Metformin Hydrochloride	Metformin Hydrochloride
67877-159	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
67877-414	Metformin Hydrochloride	Metformin Hydrochloride
67877-413	Metformin Hydrochloride	Metformin Hydrochloride
68071-1781	Metformin hydrochloride	Metformin hydrochloride
68071-1419	Metformin hydrochloride	Metformin hydrochloride
68071-1815	Metformin hydrochloride	Metformin hydrochloride
68071-3117	Metformin hydrochloride	Metformin hydrochloride
68071-3200	Metformin hydrochloride	Metformin hydrochloride
68071-1774	Metformin hydrochloride	Metformin hydrochloride
68071-3226	Metformin Hydrochloride	Metformin Hydrochloride
68071-1927	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
68071-3370	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
68071-3126	Metformin hydrochloride	Metformin hydrochloride
68071-3212	Metformin Hydrochloride	Metformin Hydrochloride
68071-4153	Metformin Hydrochloride	Metformin Hydrochloride
68071-4525	Metformin hydrochloride	Metformin hydrochloride
68071-4560	Metformin hydrochloride	Metformin hydrochloride
68071-4605	Metformin hydrochloride	Metformin hydrochloride
68071-4270	Metformin Hydrochloride	Metformin Hydrochloride