DrugDashboards

Metformin hydrochloride

Metformin hydrochloride · METFORMIN HYDROCHLORIDE 500 mg/1 · Tablet, Extended Release · Oral · Unichem Pharmaceuticals (Usa), Inc.

NDC 76385-0128-01 · 100 TABLET, EXTENDED RELEASE in 1 BOTTLE · ANDA · View full market →

The short version

24 companies supply this market — deep enough that no single failure threatens the supply.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for metformin hydrochloride (oral solid) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
ANDA207427
TE code
—
Approval date
—
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedAug 19, 2020
    BAYSHORE PHARMACEUTICALS — CGMP Deviations
  • Class II · TerminatedAug 19, 2020
    BAYSHORE PHARMACEUTICALS — CGMP Deviations

Manufacturers of Metformin hydrochloride (Tablet, Extended Release)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsMETFORMIN HYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 3, 2026
Ajanta Pharma USA Inc.METFORMIN HYDROCHLORIDE 1000 mg/1Jul 15, 2026Sep 3, 2026
Aphena Pharma Solutions - Tennessee, LLCMETFORMIN HYDROCHLORIDE 750 mg/1Jul 15, 2026Sep 3, 2026
Aphena Pharma Solutions - Tennessee, LLCMETFORMIN HYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 3, 2026
Ascend Laboratories, LLCMETFORMIN HYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 3, 2026
Aurobindo Pharma LimitedMETFORMIN HYDROCHLORIDE 750 mg/1Jul 15, 2026Sep 3, 2026
Aurobindo Pharma LimitedMETFORMIN HYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackMETFORMIN HYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackMETFORMIN HYDROCHLORIDE 750 mg/1Jul 15, 2026Sep 3, 2026
Lupin Pharmaceuticals, Inc.METFORMIN HYDROCHLORIDE 1000 mg/1Jul 15, 2026Sep 3, 2026
Marlex Pharmaceuticals, Inc.METFORMIN HYDROCHLORIDE 750 mg/1Sep 3, 2026Sep 3, 2026
Marlex Pharmaceuticals, Inc.METFORMIN HYDROCHLORIDE 500 mg/1Sep 3, 2026Sep 3, 2026
Northwind Health Company, LLCMETFORMIN HYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 3, 2026
NuCare Pharmaceuticals, Inc.METFORMIN HYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 3, 2026
Preferred Pharmaceuticals Inc.METFORMIN HYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 3, 2026
Proficient Rx LPMETFORMIN HYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 3, 2026
Proficient Rx LPMETFORMIN HYDROCHLORIDE 750 mg/1Jul 15, 2026Sep 3, 2026
Remedyrepack Inc.METFORMIN HYDROCHLORIDE 750 mg/1Jul 15, 2026Sep 3, 2026
Ascend Laboratories, LLCMETFORMIN HYDROCHLORIDE 750 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedMETFORMIN HYDROCHLORIDE 1000 mg/1Jul 15, 2026Sep 2, 2026
AvKAREMETFORMIN HYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 2, 2026
AvKAREMETFORMIN HYDROCHLORIDE 750 mg/1Jul 15, 2026Sep 2, 2026
AvPAKMETFORMIN HYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 2, 2026
AvPAKMETFORMIN HYDROCHLORIDE 750 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackMETFORMIN HYDROCHLORIDE 1000 mg/1Jul 15, 2026Sep 2, 2026
Calvin Scott & Co., Inc.METFORMIN HYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 2, 2026
Coupler LLCMETFORMIN HYDROCHLORIDE 750 mg/1Jul 15, 2026Sep 2, 2026
Epic Pharma, LLCMETFORMIN HYDROCHLORIDE 750 mg/1Jul 15, 2026Sep 2, 2026
Epic Pharma, LLCMETFORMIN HYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 2, 2026
Granules India LtdMETFORMIN HYDROCHLORIDE 1000 mg/1Jul 15, 2026Sep 2, 2026
Granules India LtdMETFORMIN HYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 2, 2026
Granules Pharmaceuticals Inc.METFORMIN HYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 2, 2026
Granules Pharmaceuticals Inc.METFORMIN HYDROCHLORIDE 1000 mg/1Jul 15, 2026Sep 2, 2026
Laurus Labs LimitedMETFORMIN HYDROCHLORIDE 750 mg/1Jul 15, 2026Sep 2, 2026
Laurus Labs LimitedMETFORMIN HYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 2, 2026
Leading Pharma, LLCMETFORMIN HYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedMETFORMIN HYDROCHLORIDE 500 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedMETFORMIN HYDROCHLORIDE 750 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedMETFORMIN HYDROCHLORIDE 1000 mg/1Jul 15, 2026Sep 2, 2026
Marksans Pharma LimitedMETFORMIN HYDROCHLORIDE 750 mg/1Jul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Metformin hydrochloride — NDC 76385-0128-01," retrieved September 3, 2026, https://drugdashboards.com/drug/76385012801.

Free to cite with attribution — see how the data is put together.