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Promethazine Hydrochloride and Phenylephrine Hydrochloride
Promethazine and Phenylephrine · PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL; PHENYLEPHRINE HYDROCHLORIDE 5 mg/5mL · Solution · Oral · Amneal Pharmaceuticals LLC
NDC 65162-0679-86 · 118 mL 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.
Where it's made
- Amneal Pharmaceuticals, LLCUnited Statesanalysis · label · manufacture · pack
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- ANDA040902
- TE code
- AA
- Approval date
- Aug 25, 2009
- 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 Promethazine and Phenylephrine (Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Amneal Pharmaceuticals LLC | PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL; PHENYLEPHRINE HYDROCHLORIDE 5 mg/5mL | Aug 26, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals LLC | PROMETHAZINE HYDROCHLORIDE 5 mg/5mL; PHENYLEPHRINE HYDROCHLORIDE 6.25 mg/5mL | Jul 22, 2026 | Aug 19, 2026 |
| Amneal Pharmaceuticals LLC | PHENYLEPHRINE HYDROCHLORIDE 5 mg/5mL; PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Promethazine Hydrochloride and Phenylephrine Hydrochloride — NDC 65162-0679-86," retrieved September 3, 2026, https://drugdashboards.com/drug/65162067986.
Free to cite with attribution — see how the data is put together.