The short version
5 companies supply this market — a reasonable cushion if one runs into trouble.
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Sodium Phenylacetate and sodium benzoate
Sodium Phenylacetate and sodium benzoate · SODIUM PHENYLACETATE 100 mg/mL; SODIUM BENZOATE 100 mg/mL · Injection, Solution, Concentrate · Intravenous · Navinta LLC
NDC 68475-0001-50 · 1 VIAL in 1 CARTON / 50 mL in 1 VIAL · 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.
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
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA205880
- TE code
- AP
- Approval date
- Aug 4, 2016
- 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 Sodium Phenylacetate and sodium benzoate (Injection, Solution, Concentrate)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Navinta LLC | SODIUM PHENYLACETATE 100 mg/mL; SODIUM BENZOATE 100 mg/mL | Jul 22, 2026 | Sep 3, 2026 |
| Omnivium Pharmaceuticals LLC | SODIUM PHENYLACETATE 100 mg/mL; SODIUM BENZOATE 100 mg/mL | Jul 22, 2026 | Sep 3, 2026 |
| Zydus Pharmaceuticals USA Inc. | SODIUM PHENYLACETATE 100 mg/mL; SODIUM BENZOATE 100 mg/mL | Jul 22, 2026 | Sep 3, 2026 |
| Ailex Pharmaceuticals, LLC | SODIUM PHENYLACETATE 100 mg/mL; SODIUM BENZOATE 100 mg/mL | Jul 22, 2026 | Sep 2, 2026 |
| Maia Pharmaceuticals, Inc | SODIUM PHENYLACETATE 100 mg/mL; SODIUM BENZOATE 100 mg/mL | Jul 22, 2026 | Sep 2, 2026 |
| Navinta LLC | SODIUM BENZOATE 100 mg/mL; SODIUM PHENYLACETATE 100 mg/mL | Jul 15, 2026 | Jul 19, 2026 |
| Omnivium Pharmaceuticals LLC | SODIUM BENZOATE 100 mg/mL; SODIUM PHENYLACETATE 100 mg/mL | Jul 15, 2026 | Jul 19, 2026 |
| Zydus Pharmaceuticals USA Inc. | SODIUM BENZOATE 100 mg/mL; SODIUM PHENYLACETATE 100 mg/mL | Jul 15, 2026 | Jul 19, 2026 |
| Ailex Pharmaceuticals, LLC | SODIUM BENZOATE 100 mg/mL; SODIUM PHENYLACETATE 100 mg/mL | Jul 15, 2026 | Jul 15, 2026 |
| Maia Pharmaceuticals, Inc | SODIUM BENZOATE 100 mg/mL; SODIUM PHENYLACETATE 100 mg/mL | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Sodium Phenylacetate and sodium benzoate — NDC 68475-0001-50," retrieved September 3, 2026, https://drugdashboards.com/drug/68475000150.
Free to cite with attribution — see how the data is put together.