The short version
Just 3 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Darunavir 600 and 800 mg
darunavir · DARUNAVIR DIHYDRATE 800 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC 63629-5686-01 · 15 TABLET in 1 BOTTLE · ANDA · View full market →
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 darunavir (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 →
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 $1,077.25 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA206288
- TE code
- AB
- Approval date
- Nov 28, 2023
- 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 darunavir (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| American Health Packaging | DARUNAVIR DIHYDRATE 600 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| American Health Packaging | DARUNAVIR DIHYDRATE 800 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Bryant Ranch Prepack | DARUNAVIR DIHYDRATE 800 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Cipla USA Inc. | DARUNAVIR HYDRATE 600 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Cipla USA Inc. | DARUNAVIR HYDRATE 800 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, "Darunavir 600 and 800 mg — NDC 63629-5686-01," retrieved September 3, 2026, https://drugdashboards.com/drug/63629568601.
Free to cite with attribution — see how the data is put together.