The short version
12 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.
Ondansetron
Ondansetron · ONDANSETRON HYDROCHLORIDE 4 mg/1 · Tablet, Film Coated · Oral · PharmPak, Inc.
NDC 54348-0819-00 · 1 BOTTLE in 1 BOX / 1 TABLET, FILM COATED 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)
0.2%chance of a new FDA shortage posting for ondansetron (oral solid) in the next 90 days
OAI inspection at a producing facility (24 months) · sole-source market · 1 Class I/II recall(s) in 12 months
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
- ANDA078539
- TE code
- AB
- Approval date
- Jul 31, 2007
- 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 Ondansetron (Tablet, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| HF Acquisition Co LLC, DBA HealthFirst | ONDANSETRON HYDROCHLORIDE 4 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Bryant Ranch Prepack | ONDANSETRON HYDROCHLORIDE 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Direct_Rx | ONDANSETRON HYDROCHLORIDE 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Glenmark Pharmaceuticals Inc., USA | ONDANSETRON HYDROCHLORIDE 8 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Glenmark Pharmaceuticals Inc., USA | ONDANSETRON HYDROCHLORIDE 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| NorthStar Rx LLC | ONDANSETRON HYDROCHLORIDE 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| NorthStar Rx LLC | ONDANSETRON HYDROCHLORIDE 8 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| PD-Rx Pharmaceuticals, Inc. | ONDANSETRON HYDROCHLORIDE 8 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| PharmPak, Inc. | ONDANSETRON HYDROCHLORIDE 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Proficient Rx LP | ONDANSETRON HYDROCHLORIDE 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Proficient Rx LP | ONDANSETRON HYDROCHLORIDE 8 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Redpharm Drug | ONDANSETRON HYDROCHLORIDE 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Remedyrepack Inc. | ONDANSETRON HYDROCHLORIDE 8 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | ONDANSETRON HYDROCHLORIDE 8 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | ONDANSETRON HYDROCHLORIDE 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| NuCare Pharmaceuticals, Inc. | ONDANSETRON HYDROCHLORIDE 8 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, "Ondansetron — NDC 54348-0819-00," retrieved September 3, 2026, https://drugdashboards.com/drug/54348081900.
Free to cite with attribution — see how the data is put together.