Prescription drug · ANDA
Pralatrexate NDC 43598-343
Pralatrexate 40 mg/2mL · Injection · Intravenous · Dr.Reddy's Laboratories Inc.,
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-343-23 | 43598034323 | 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-343-23) / 2 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 — 40 mg/2mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206183
- Marketing start
- Listing expires
- Identifiers
- Product ID 43598-343_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.
- NDC on a medical claim
N443598034323followed by a unit qualifier and the quantityPackage 43598-0343-23. 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 .
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.