The short version
18 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.
Fingolimod
Fingolimod · FINGOLIMOD HYDROCHLORIDE .5 mg/1 · Capsule · Oral · Biocon Pharma Inc.
NDC 70377-0019-21 · 28 CAPSULE in 1 CARTON · 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 fingolimod (oral solid) in the next 90 days
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 →
Where it's made
- Biocon LimitedIndiaapi manufacture
- manufacture
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 $2,055.06 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA207979
- TE code
- AB
- Approval date
- Dec 4, 2019
- 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 Fingolimod (Capsule)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Alembic Pharmaceuticals Inc. | FINGOLIMOD HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Limited | FINGOLIMOD HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Apotex Corp. | FINGOLIMOD HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | FINGOLIMOD HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| AvKARE | FINGOLIMOD HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Biocon Pharma Inc. | FINGOLIMOD HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | FINGOLIMOD HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| CivicaScript LLC | FINGOLIMOD HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Dr. Reddy's Laboratories Inc | FINGOLIMOD HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Glenmark Pharmaceuticals Inc., USA | FINGOLIMOD HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Quallent Pharmaceuticals Health LLC | FINGOLIMOD HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Solco Healthcare US, LLC | FINGOLIMOD .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | FINGOLIMOD HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Teva Pharmaceuticals, Inc. | FINGOLIMOD HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| XLCare Pharmaceuticals Inc. | FINGOLIMOD HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | FINGOLIMOD HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | FINGOLIMOD HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novadoz Pharmaceuticals LLC | FINGOLIMOD HYDROCHLORIDE .5 mg/1 | Aug 28, 2026 | Aug 28, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Fingolimod — NDC 70377-0019-21," retrieved September 3, 2026, https://drugdashboards.com/drug/70377001921.
Free to cite with attribution — see how the data is put together.