DrugDashboards

Janumet

SITAGLIPTIN and METFORMIN HYDROCHLORIDE · SITAGLIPTIN PHOSPHATE 50 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1 · Tablet, Film Coated · Oral · Merck Sharp & Dohme LLC

NDC 00006-0577-03 · 2 BOTTLE in 1 CARTON / 14 TABLET, FILM COATED in 1 BOTTLE · NDA · View full market →

The short version

9 companies supply this market — a reasonable cushion if one runs into trouble.

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

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00006-0577-61) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$5.28per unit
middle half $5.21$5.55 · 5,232 plans · Apr 1, 2026
Est. net of rebates
$3.17–$3.96
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
95%of plans cover it
tier 3 · prior auth 0% · step therapy 0% · qty limit 97%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

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 sitagliptin and metformin hydrochloride (oral solid) in the next 90 days

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 →

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $953.32 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA022044
TE code
AB
Approval date
Mar 30, 2007
Patents / exclusivity
8 patents, 0 exclusivities
TypeNumber / codeExpires
patent8414921*PEDJan 21, 2029
patent8414921*PEDJan 21, 2029
patent8414921Jul 21, 2028
patent8414921Jul 21, 2028
patent7326708*PEDMay 24, 2027
patent7326708*PEDMay 24, 2027
patent7326708Nov 24, 2026
patent7326708Nov 24, 2026

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedMar 31, 2022
    MERCK SHARP & DOHME CORPPresence of foreign substance: Presence of stainless steel particulates in tablets.

Manufacturers of SITAGLIPTIN and METFORMIN HYDROCHLORIDE (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
MSD International GmbH (Singapore Branch)SITAGLIPTIN PHOSPHATE 50 mg/1; METFORMIN HYDROCHLORIDE 500 mg/1Aug 20, 2026Sep 3, 2026
Patheon Puerto Rico, Inc.SITAGLIPTIN PHOSPHATE 50 mg/1; METFORMIN HYDROCHLORIDE 500 mg/1Aug 20, 2026Sep 3, 2026
Patheon Puerto Rico, Inc.SITAGLIPTIN PHOSPHATE 50 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1Aug 20, 2026Sep 3, 2026
Zydus Lifesciences LimitedSITAGLIPTIN 50 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1Aug 26, 2026Sep 3, 2026
A-S Medication SolutionsSITAGLIPTIN PHOSPHATE 50 mg/1; METFORMIN HYDROCHLORIDE 500 mg/1Aug 26, 2026Sep 2, 2026
A-S Medication SolutionsSITAGLIPTIN PHOSPHATE 50 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1Aug 26, 2026Sep 2, 2026
Apotex Corp.SITAGLIPTIN PHOSPHATE 50 mg/1; METFORMIN HYDROCHLORIDE 500 mg/1Aug 26, 2026Sep 2, 2026
Apotex Corp.SITAGLIPTIN PHOSPHATE 50 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1Aug 26, 2026Sep 2, 2026
Golden State Medical Supply, Inc.SITAGLIPTIN PHOSPHATE 50 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1Aug 26, 2026Sep 2, 2026
Golden State Medical Supply, Inc.SITAGLIPTIN PHOSPHATE 50 mg/1; METFORMIN HYDROCHLORIDE 500 mg/1Aug 26, 2026Sep 2, 2026
Merck Sharp & Dohme LLCSITAGLIPTIN PHOSPHATE 50 mg/1; METFORMIN HYDROCHLORIDE 500 mg/1Aug 26, 2026Sep 2, 2026
Merck Sharp & Dohme LLCSITAGLIPTIN PHOSPHATE 50 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1Aug 26, 2026Sep 2, 2026
Sandoz IncSITAGLIPTIN PHOSPHATE 50 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1Aug 26, 2026Sep 2, 2026
Sandoz IncSITAGLIPTIN PHOSPHATE 50 mg/1; METFORMIN HYDROCHLORIDE 500 mg/1Aug 26, 2026Sep 2, 2026
Zydus Pharmaceuticals (USA) Inc.SITAGLIPTIN 50 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1Aug 26, 2026Sep 2, 2026
Patheon Puerto Rico, Inc.SITAGLIPTIN PHOSPHATE 50 mg/1; METFORMIN HYDROCHLORIDE 850 mg/1Aug 20, 2026Aug 31, 2026
Zydus Lifesciences LimitedSITAGLIPTIN 50 mg/1; METFORMIN HYDROCHLORIDE 500 mg/1Aug 26, 2026Aug 31, 2026
Zydus Pharmaceuticals (USA) Inc.SITAGLIPTIN 50 mg/1; METFORMIN HYDROCHLORIDE 500 mg/1Aug 26, 2026Aug 28, 2026
Golden State Medical Supply, Inc.SITAGLIPTIN PHOSPHATE 1000 mg/1; METFORMIN HYDROCHLORIDE 50 mg/1Aug 15, 2026Aug 22, 2026
Golden State Medical Supply, Inc.SITAGLIPTIN PHOSPHATE 500 mg/1; METFORMIN HYDROCHLORIDE 50 mg/1Aug 15, 2026Aug 22, 2026
Zydus Pharmaceuticals (USA) Inc.SITAGLIPTIN 1000 mg/1; METFORMIN HYDROCHLORIDE 50 mg/1Jul 22, 2026Aug 22, 2026
Zydus Lifesciences LimitedSITAGLIPTIN 1000 mg/1; METFORMIN HYDROCHLORIDE 50 mg/1Jul 22, 2026Aug 21, 2026
Zydus Lifesciences LimitedSITAGLIPTIN 500 mg/1; METFORMIN HYDROCHLORIDE 50 mg/1Jul 22, 2026Aug 21, 2026
Zydus Pharmaceuticals (USA) Inc.SITAGLIPTIN 500 mg/1; METFORMIN HYDROCHLORIDE 50 mg/1Jul 22, 2026Aug 21, 2026
A-S Medication SolutionsSITAGLIPTIN PHOSPHATE 500 mg/1; METFORMIN HYDROCHLORIDE 50 mg/1Jul 22, 2026Aug 19, 2026
A-S Medication SolutionsSITAGLIPTIN PHOSPHATE 1000 mg/1; METFORMIN HYDROCHLORIDE 50 mg/1Jul 22, 2026Aug 19, 2026
Apotex Corp.SITAGLIPTIN PHOSPHATE 500 mg/1; METFORMIN HYDROCHLORIDE 50 mg/1Jul 22, 2026Aug 19, 2026
Apotex Corp.SITAGLIPTIN PHOSPHATE 1000 mg/1; METFORMIN HYDROCHLORIDE 50 mg/1Jul 22, 2026Aug 19, 2026
Merck Sharp & Dohme LLCSITAGLIPTIN PHOSPHATE 1000 mg/1; METFORMIN HYDROCHLORIDE 50 mg/1Jul 22, 2026Aug 19, 2026
Merck Sharp & Dohme LLCSITAGLIPTIN PHOSPHATE 500 mg/1; METFORMIN HYDROCHLORIDE 50 mg/1Jul 22, 2026Aug 19, 2026
MSD International GmbH (Singapore Branch)SITAGLIPTIN PHOSPHATE 500 mg/1; METFORMIN HYDROCHLORIDE 50 mg/1Jul 22, 2026Aug 19, 2026
Patheon Puerto Rico, Inc.SITAGLIPTIN PHOSPHATE 1000 mg/1; METFORMIN HYDROCHLORIDE 50 mg/1Jul 22, 2026Aug 19, 2026
Patheon Puerto Rico, Inc.SITAGLIPTIN PHOSPHATE 500 mg/1; METFORMIN HYDROCHLORIDE 50 mg/1Jul 22, 2026Aug 19, 2026
Sandoz IncSITAGLIPTIN PHOSPHATE 500 mg/1; METFORMIN HYDROCHLORIDE 50 mg/1Jul 22, 2026Aug 19, 2026
Sandoz IncSITAGLIPTIN PHOSPHATE 1000 mg/1; METFORMIN HYDROCHLORIDE 50 mg/1Jul 22, 2026Aug 19, 2026
Patheon Puerto Rico, Inc.SITAGLIPTIN PHOSPHATE 850 mg/1; METFORMIN HYDROCHLORIDE 50 mg/1Jul 22, 2026Aug 16, 2026
Zydus Lifesciences LimitedMETFORMIN HYDROCHLORIDE 1000 mg/1; SITAGLIPTIN 50 mg/1Jul 15, 2026Jul 19, 2026
Zydus Lifesciences LimitedMETFORMIN HYDROCHLORIDE 500 mg/1; SITAGLIPTIN 50 mg/1Jul 15, 2026Jul 19, 2026
Zydus Pharmaceuticals (USA) Inc.METFORMIN HYDROCHLORIDE 1000 mg/1; SITAGLIPTIN 50 mg/1Jul 15, 2026Jul 18, 2026
Patheon Puerto Rico, Inc.METFORMIN HYDROCHLORIDE 850 mg/1; SITAGLIPTIN PHOSPHATE 50 mg/1Jul 15, 2026Jul 16, 2026

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

Cite this page

DrugDashboards, "Janumet — NDC 00006-0577-03," retrieved September 3, 2026, https://drugdashboards.com/drug/00006057703.

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