What is NDC 65219-552?

65219-552 is the product NDC for Pralatrexate, Pralatrexate 40 mg/2mL injection, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Pralatrexate?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pralatrexate NDC 65219-552 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-552Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0552Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
65219-552-02	6521905520265219055202	1 VIAL, SINGLE-DOSE in 1 CARTON (65219-552-02) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 15, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Pralatrexate
Generic name (nonproprietary): pralatrexate
Active ingredients: Pralatrexate — 40 mg/2mL
Dosage form: Injection
Route: Intravenous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 65219
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 022468
Marketing start: Nov 15, 2022
Listing expires: Dec 31, 2027
Identifiers: Product ID 65219-552_510bc71b-20e4-428a-8fc2-29c9fc20f2f3SPL ID 510bc71b-20e4-428a-8fc2-29c9fc20f2f3SPL set ID a5daa583-4965-4564-ad87-41ffe6c08a11RxCUI 1796419, 1796424UNII A8Q8I19Q20
Pharmacologic class: Folate Analog Metabolic Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N465219055202 followed by a unit qualifier and the quantity

Package 65219-0552-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Nov 15, 2022.

Indications (excerpt from the label)

Pralatrexate injection is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Pralatrexate injection is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65219-552

What is NDC 65219-552?: 65219-552 is the product NDC for Pralatrexate, Pralatrexate 40 mg/2mL injection, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Pralatrexate.
What is the active ingredient?: Pralatrexate.
Who is the labeler?: Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pralatrexate?: 3 other product NDCs are listed under this name. See all Pralatrexate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Pralatrexate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Pralatrexate	Pralatrexate 20 mg/mL	InjectionIntravenous	Dr.Reddy's Laboratories Inc.,	43598-342	43598-0342-11
Pralatrexate	Pralatrexate 40 mg/2mL	InjectionIntravenous	Dr.Reddy's Laboratories Inc.,	43598-343	43598-0343-23
Pralatrexate	Pralatrexate 20 mg/mL	InjectionIntravenous	Fresenius Kabi USA, LLC	65219-550	65219-0550-01

Other NDCs under NDA 022468

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 022468
Product	Strength	Form · route	Labeler	Product NDC
Folotynpralatrexate	Pralatrexate 20 mg/mL	InjectionIntravenous	Acrotech Biopharma Inc	72893-003
Folotynpralatrexate	Pralatrexate 40 mg/2mL	InjectionIntravenous	Acrotech Biopharma Inc	72893-005
Pralatrexate	Pralatrexate 20 mg/mL	InjectionIntravenous	Fresenius Kabi USA, LLC	65219-550