The short version
13 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.
Cevimeline Hydrochloride
Cevimeline Hydrochloride · CEVIMELINE HYDROCHLORIDE 30 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC 63629-9863-01 · 30 CAPSULE in 1 BOTTLE · ANDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 00713-0883-01) — 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ⓘ
$8.03per unit
middle half $8.03–$8.51 · 10 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $8.03
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 4 · 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 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 cevimeline 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 →
Where it's made
- Bryant Ranch PrepackUnited Statesrelabel · repack
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- ANDA203775
- TE code
- AB
- Approval date
- Jun 4, 2014
- 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 Cevimeline Hydrochloride (Capsule)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Aurobindo Pharma Limited | CEVIMELINE HYDROCHLORIDE 30 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Bryant Ranch Prepack | CEVIMELINE HYDROCHLORIDE 30 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Cosette Pharmaceuticals, Inc. | CEVIMELINE HYDROCHLORIDE 30 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Advagen Pharma Ltd | CEVIMELINE HYDROCHLORIDE 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Asclemed Usa Inc. | CEVIMELINE HYDROCHLORIDE 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Bionpharma Inc | CEVIMELINE HYDROCHLORIDE 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Hikma Pharmaceuticals USA Inc. | CEVIMELINE HYDROCHLORIDE 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Macleods Pharmaceuticals Limited | CEVIMELINE HYDROCHLORIDE 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novel Laboratories, Inc. | CEVIMELINE HYDROCHLORIDE 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| PD-Rx Pharmaceuticals, Inc. | CEVIMELINE HYDROCHLORIDE 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Rising Pharma Holdings, Inc. | CEVIMELINE HYDROCHLORIDE 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Viona Pharmaceuticals Inc | CEVIMELINE HYDROCHLORIDE 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | CEVIMELINE HYDROCHLORIDE 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Cevimeline Hydrochloride — NDC 63629-9863-01," retrieved September 3, 2026, https://drugdashboards.com/drug/63629986301.
Free to cite with attribution — see how the data is put together.