Pralatrexate

Pralatrexate · PRALATREXATE 40 mg/2mL · Injection · Intravenous · Fresenius Kabi USA, LLC

NDC 65219-0552-02 · 1 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE · NDA AUTHORIZED GENERIC · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. One of its named manufacturing plants, Simtra Deutschland GmbH, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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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.

Estimated fill cost

WAC per package, as filed

$9,963.94

Reported to Texas DSHS · 2024 annual filing · Fresenius Kabi Usa

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

Medicare Part B (ASP)

Payment limit per 1 MG

$386.122

HCPCS J9307 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2024)

$275,175

18 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

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

Where it's made

Simtra Deutschland GmbHOAIGermany
manufacture

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
Biologic (BLA)
Injectable / infused
Orphan-drug exclusivity
REMS program

Regulatory

Application: NDA022468
TE code: AP
Approval date: Sep 24, 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 Pralatrexate (Injection)

Labeler	Strength	First seen	Last seen
Acrotech Biopharma Inc	PRALATREXATE 20 mg/mL	Jul 15, 2026	Sep 2, 2026
Acrotech Biopharma Inc	PRALATREXATE 40 mg/2mL	Jul 15, 2026	Sep 2, 2026
Dr.Reddy's Laboratories Inc.,	PRALATREXATE 20 mg/mL	Jul 15, 2026	Sep 2, 2026
Dr.Reddy's Laboratories Inc.,	PRALATREXATE 40 mg/2mL	Jul 15, 2026	Sep 2, 2026
Fresenius Kabi USA, LLC	PRALATREXATE 20 mg/mL	Jul 15, 2026	Sep 2, 2026
Fresenius Kabi USA, LLC	PRALATREXATE 40 mg/2mL	Jul 15, 2026	Sep 2, 2026

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

Cite this page

DrugDashboards, "Pralatrexate — NDC 65219-0552-02," retrieved September 3, 2026, https://drugdashboards.com/drug/65219055202.

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