NDC 43353-987

METFORMIN HYDROCHLORIDE

Metformin Hydrochloride

METFORMIN HYDROCHLORIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Metformin Hydrochloride.

• Product ID: 43353-987_600cc6bc-4c96-40d8-8530-bfaaa5688510
• NDC: 43353-987
• Product Type: Human Prescription Drug
• Proprietary Name: METFORMIN HYDROCHLORIDE
• Generic Name: Metformin Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2013-09-11
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203769
• Labeler Name: Aphena Pharma Solutions - Tennessee, LLC
• Substance Name: METFORMIN HYDROCHLORIDE
• Active Ingredient Strength: 1000 mg/1
• Pharm Classes: Biguanide [EPC],Biguanides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 43353-987-30

30 TABLET in 1 BOTTLE (43353-987-30)

• Marketing Start Date: 2014-12-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43353-987-45 [43353098745]

METFORMIN HYDROCHLORIDE TABLET

• Marketing Category: ANDA
• Application Number: ANDA203769
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-01-05

NDC 43353-987-86 [43353098786]

METFORMIN HYDROCHLORIDE TABLET

• Marketing Category: ANDA
• Application Number: ANDA203769
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-12-22

NDC 43353-987-73 [43353098773]

METFORMIN HYDROCHLORIDE TABLET

• Marketing Category: ANDA
• Application Number: ANDA203769
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-12-21

NDC 43353-987-80 [43353098780]

METFORMIN HYDROCHLORIDE TABLET

• Marketing Category: ANDA
• Application Number: ANDA203769
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-02-02

NDC 43353-987-30 [43353098730]

METFORMIN HYDROCHLORIDE TABLET

• Marketing Category: ANDA
• Application Number: ANDA203769
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-12-22

NDC 43353-987-53 [43353098753]

METFORMIN HYDROCHLORIDE TABLET

• Marketing Category: ANDA
• Application Number: ANDA203769
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-02-24

NDC 43353-987-60 [43353098760]

METFORMIN HYDROCHLORIDE TABLET

• Marketing Category: ANDA
• Application Number: ANDA203769
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-02-02

Drug Details

Active Ingredients

Ingredient	Strength
METFORMIN HYDROCHLORIDE	1000 mg/1

OpenFDA Data

• SPL SET ID: 273d86b0-9d30-48c9-8918-c5e1ececa951
• Manufacturer:
  • Aphena Pharma Solutions - Tennessee, LLC
• UNII:
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 861007
  • 861010
  • 861004

Pharmacological Class

• 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