DrugDashboards

Ambrisentan

Ambrisentan · AMBRISENTAN 5 mg/1 · Tablet, Film Coated · Oral · Cipla USA Inc.

NDC 69097-0386-19 · 1 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK · ANDA · View full market →

The short version

13 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.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 61958-0801-01) — 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
$491.02per unit
middle half $490.59$491.02 · 8 plans · Apr 1, 2026
Est. net of rebates
≈ $491.02
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 5 · prior auth 100% · step therapy 0% · qty limit 25%

*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 10 quarters since 2024.

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)

0.1%chance of a new FDA shortage posting for ambrisentan (oral solid) in the next 90 days

sole-source market

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 →

Where it's made

  • analysis · api manufacture · label · manufacture · pack

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 $3,148.66 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA210715
TE code
AB
Approval date
Apr 26, 2019
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 Ambrisentan (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsAMBRISENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
A-S Medication SolutionsAMBRISENTAN 5 mg/1Jul 15, 2026Sep 2, 2026
Apotex Corp.AMBRISENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Apotex Corp.AMBRISENTAN 5 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedAMBRISENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedAMBRISENTAN 5 mg/1Jul 15, 2026Sep 2, 2026
Cipla USA Inc.AMBRISENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Cipla USA Inc.AMBRISENTAN 5 mg/1Jul 15, 2026Sep 2, 2026
Gilead Sciences, Inc.AMBRISENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Gilead Sciences, Inc.AMBRISENTAN 5 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.AMBRISENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.AMBRISENTAN 5 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.AMBRISENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.AMBRISENTAN 5 mg/1Jul 15, 2026Sep 2, 2026
Quallent Pharmaceuticals Health LLCAMBRISENTAN 5 mg/1Jul 15, 2026Sep 2, 2026
Quallent Pharmaceuticals Health LLCAMBRISENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Sigmapharm Laboratories, LLCAMBRISENTAN 5 mg/1Jul 15, 2026Sep 2, 2026
Sigmapharm Laboratories, LLCAMBRISENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.AMBRISENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.AMBRISENTAN 5 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedAMBRISENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedAMBRISENTAN 5 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.AMBRISENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.AMBRISENTAN 5 mg/1Jul 15, 2026Sep 2, 2026
Actavis Pharma, Inc.AMBRISENTAN 10 mg/1Jul 15, 2026Aug 31, 2026
Actavis Pharma, Inc.AMBRISENTAN 5 mg/1Jul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Ambrisentan — NDC 69097-0386-19," retrieved September 3, 2026, https://drugdashboards.com/drug/69097038619.

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