Roflumilast
Roflumilast · ROFLUMILAST 500 ug/1 · Tablet · Corden Pharma GmbH
NDC 43265-7463-01 · 2 BAG in 1 DRUM / 152671 TABLET in 1 BAG · DRUG FOR FURTHER PROCESSING · View full market →
Bulk ingredient — not a finished product
This NDC is a raw material (drug for further processing) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 00310-0095-30) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.
ⓘ How this was built
- CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
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.
*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)
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 →
Regulatory
- Application
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- TE code
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- Approval date
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- Patents / exclusivity
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Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Roflumilast (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| American Health Packaging | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amici Pharma Inc. | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amici Pharma Inc. | ROFLUMILAST 250 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | ROFLUMILAST 250 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| AstraZeneca Pharmaceuticals LP | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| AstraZeneca Pharmaceuticals LP | ROFLUMILAST 250 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | ROFLUMILAST 250 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| AvKARE | ROFLUMILAST 250 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| AvKARE | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Bryant Ranch Prepack | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | ROFLUMILAST 250 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Corden Pharma GmbH | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Corden Pharma GmbH | ROFLUMILAST 250 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Golden State Medical Supply, Inc. | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Jubilant Cadista Pharmaceuticals Inc. | ROFLUMILAST 250 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Jubilant Cadista Pharmaceuticals Inc. | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Major Pharmaceuticals | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Major Pharmaceuticals | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Major Pharmaceuticals | ROFLUMILAST 250 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Micro Labs Limited | ROFLUMILAST 250 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Micro Labs Limited | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novadoz Pharmaceuticals LLC | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novadoz Pharmaceuticals LLC | ROFLUMILAST 250 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Solco Healthcare US, LLC. | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Strides Pharma Science Limited | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Takeda GmbH | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Takeda GmbH | ROFLUMILAST 250 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | ROFLUMILAST 250 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | ROFLUMILAST 250 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | ROFLUMILAST 500 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Roflumilast — NDC 43265-7463-01," retrieved September 3, 2026, https://drugdashboards.com/drug/43265746301.
Free to cite with attribution — see how the data is put together.