The short version
7 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.
isosorbide mononitrate
isosorbide mononitrate · ISOSORBIDE MONONITRATE 10 mg/1 · Tablet · Oral · Coupler LLC
NDC 67046-1577-03 · 30 TABLET in 1 BLISTER PACK · NDA AUTHORIZED GENERIC · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 81665-0102-10) — 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ⓘ
$1.02per unit
middle half $0.4397–$1.86 · 4,095 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $1.02
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
75%of plans cover it
tier 1 · prior auth 0% · step therapy 0% · qty limit 0%
*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 5 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 isosorbide mononitrate (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 →
Where it's made
- Coupler LLCUnited Statesrepack
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- NDA020215
- TE code
- AB
- Approval date
- Jun 30, 1993
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of isosorbide mononitrate (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Coupler LLC | ISOSORBIDE MONONITRATE 10 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| ANI Pharmaceuticals, Inc. | ISOSORBIDE MONONITRATE 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| ANI Pharmaceuticals, Inc. | ISOSORBIDE MONONITRATE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Coupler LLC | ISOSORBIDE MONONITRATE 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Genus Lifesciences Inc. | ISOSORBIDE MONONITRATE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Genus Lifesciences Inc. | ISOSORBIDE MONONITRATE 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lannett Company, Inc. | ISOSORBIDE MONONITRATE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lannett Company, Inc. | ISOSORBIDE MONONITRATE 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Omnivium Pharmaceuticals Llc. | ISOSORBIDE MONONITRATE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Omnivium Pharmaceuticals Llc. | ISOSORBIDE MONONITRATE 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Proficient Rx LP | ISOSORBIDE MONONITRATE 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Actavis Pharma, Inc. | ISOSORBIDE MONONITRATE 20 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| Actavis Pharma, Inc. | ISOSORBIDE MONONITRATE 10 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "isosorbide mononitrate — NDC 67046-1577-03," retrieved September 3, 2026, https://drugdashboards.com/drug/67046157703.
Free to cite with attribution — see how the data is put together.