DrugDashboards

sodium phenylbutyrate

sodium phenylbutyrate · SODIUM PHENYLBUTYRATE 500 mg/1 · Tablet · Oral · Glenmark Pharmaceuticals Inc., Usa

NDC 68462-0853-20 · 250 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

4 companies supply this market — a reasonable cushion if one runs into trouble. One of its named manufacturing plants, Glenmark Pharmaceuticals Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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.

  • Part D plans paid (avg)$14.07per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal contracts pay (FSS)$11.16per unitGLENMARK PHARMACEUTICALS INC., USA · Jul 24, 2024

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 75987-0060-08) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ 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
$26.82per unit
middle half $26.82$26.82 · 2 plans · Jan 1, 2026
Est. net of rebates
≈ $26.82
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 1 · prior auth 100% · 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 9 quarters since 2024.

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Estimated fill cost

WAC per package, as filed
$3,000.00
Reported to Texas DSHS · 2026 annual filing · Glenmark Pharmaceuticals Inc., USA

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

Where it's made

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 $6,478.76 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA216462
TE code
AB
Approval date
Nov 1, 2022
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 phenylbutyrate (Tablet)

LabelerStrengthFirst seenLast seen
Glenmark Pharmaceuticals Inc., UsaSODIUM PHENYLBUTYRATE 500 mg/1Jul 15, 2026Sep 2, 2026
Horizon Therapeutics USA, Inc.SODIUM PHENYLBUTYRATE 500 mg/1Jul 15, 2026Sep 2, 2026
Navinta LLCSODIUM PHENYLBUTYRATE 500 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.SODIUM PHENYLBUTYRATE 500 mg/1Jul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "sodium phenylbutyrate — NDC 68462-0853-20," retrieved September 3, 2026, https://drugdashboards.com/drug/68462085320.

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