DrugDashboards

Promethazine Hydrochloride and Phenylephrine Hydrochloride

promethazine hydrochloride and phenylephrine hydrochloride · PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL; PHENYLEPHRINE HYDROCHLORIDE 5 mg/5mL · Solution · Oral · Genus Lifesciences Inc.

NDC 64950-0345-16 · 473 mL in 1 BOTTLE, PLASTIC · ANDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. Put together: worth watching — several of the pressures that precede supply trouble are present at once.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Pharmacies pay (NADAC)$0.1632per MLinvoice-surveyed acquisition cost · Oct 16, 2024
  • Part D point of sale (median)$0.4560per unitnegotiated price across 17 plans — before rebates · Apr 1, 2026

Medicare Part D

All Part D pricing →
ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$0.4560per unit
middle half $0.4422$0.4573 · 17 plans · Apr 1, 2026
Est. net of rebates
≈ $0.4560
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 2 · prior auth 88% · step therapy 0% · qty limit 0%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 5 quarters since 2024.

NADAC price per unit

$0$0.1$0.2Oct 2024Oct 2024$0.1632
2 price points · per ML · last surveyed Invalid DateSource: CMS NADAC

Medicaid spend (2025)

$38,633
715 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

30Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 1 active manufacturer+30

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

Regulatory

Application
ANDA040654
TE code
AA
Approval date
Dec 7, 2006
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 hydrochloride and phenylephrine hydrochloride (Solution)

LabelerStrengthFirst seenLast seen
Genus Lifesciences Inc.PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL; PHENYLEPHRINE HYDROCHLORIDE 5 mg/5mLAug 26, 2026Sep 2, 2026
Genus Lifesciences Inc.PROMETHAZINE HYDROCHLORIDE 5 mg/5mL; PHENYLEPHRINE HYDROCHLORIDE 6.25 mg/5mLJul 22, 2026Aug 19, 2026
Genus Lifesciences Inc.PHENYLEPHRINE HYDROCHLORIDE 5 mg/5mL; PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mLJul 15, 2026Jul 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 64950-0345-16," retrieved September 3, 2026, https://drugdashboards.com/drug/64950034516.

Free to cite with attribution — see how the data is put together.