What is NDC 43598-342?

43598-342 is the product NDC for Pralatrexate, Pralatrexate 20 mg/mL injection, listed with the FDA by Dr.Reddy's Laboratories Inc.,. It has 1 package NDC, shown above in 10- and 11-digit form.

Dr.Reddy's Laboratories Inc.,, NDC labeler code 43598. 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 43598-342 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-342Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0342Add 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
43598-342-11	4359803421143598034211	1 VIAL, SINGLE-DOSE in 1 CARTON (43598-342-11) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 4, 2026

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 — 20 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Dr.Reddy's Laboratories Inc.,NDC labeler code 43598
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206183
Marketing start: Mar 4, 2026
Listing expires: Dec 31, 2027
Identifiers: Product ID 43598-342_b885a7b3-a241-638d-8f27-d162c562469aSPL ID b885a7b3-a241-638d-8f27-d162c562469aSPL set ID cc3df863-c51c-49c5-283a-d6808fb49258RxCUI 1796419, 1796424UNII A8Q8I19Q20UPC 0343598342115, 0343598343235
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

N443598034211 followed by a unit qualifier and the quantity

Package 43598-0342-11. 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 Aug 31, 2025.

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 43598-342

What is NDC 43598-342?: 43598-342 is the product NDC for Pralatrexate, Pralatrexate 20 mg/mL injection, listed with the FDA by Dr.Reddy's Laboratories Inc.,. 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?: Dr.Reddy's Laboratories Inc.,, NDC labeler code 43598. 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 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
Pralatrexate	Pralatrexate 40 mg/2mL	InjectionIntravenous	Fresenius Kabi USA, LLC	65219-552	65219-0552-02

Other NDCs under ANDA 206183

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

FDA NDC Directory listings under ANDA 206183
Product	Strength	Form · route	Labeler	Product NDC
Pralatrexate	Pralatrexate 40 mg/2mL	InjectionIntravenous	Dr.Reddy's Laboratories Inc.,	43598-343