Prescription drug · ANDA
Nelarabine NDC 43598-142
Nelarabine 5 mg/mL · Injection · Intravenous · Dr. Reddy's Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-142-06 | 4359801420643598014206 | 6 VIAL, SINGLE-DOSE in 1 CARTON (43598-142-06) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 9, 2023 | |
| 43598-142-11 | 4359801421143598014211 | 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-142-11) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 1, 2023 |
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)
- Nelarabine
- Generic name (nonproprietary)
- nelarabine
- Active ingredients
- Nelarabine — 5 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 216934
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 43598-142_8105c460-afd8-5eec-7857-c2e4e5b89fc3SPL ID 8105c460-afd8-5eec-7857-c2e4e5b89fc3SPL set ID 57275b05-f40f-7298-5a5e-93594bc41437RxCUI 603566UNII 60158CV180UPC 0343598142111, 0343598142067
- Pharmacologic class
- Nucleoside 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
N443598014206followed by a unit qualifier and the quantityPackage 43598-0142-06. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. Nelarabine Injection is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 43598-142
- What is NDC 43598-142?
- 43598-142 is the product NDC for Nelarabine, Nelarabine 5 mg/mL injection, listed with the FDA by Dr. Reddy's Laboratories, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nelarabine.
- What is the active ingredient?
- Nelarabine.
- 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 Nelarabine?
- 13 other product NDCs are listed under this name. See all Nelarabine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nelarabine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | Shorla Oncology Inc. | 81927-375 | 81927-0375-01 |
| Nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | XGen Pharmaceuticals DJB, Inc. | 39822-0650 | 39822-0650-0139822-0650-06 |
| Nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | Novadoz Pharmaceuticals LLC | 72205-154 | 72205-0154-0172205-0154-04 |
| Nelarabine | Nelarabine 5 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-259 | 25021-0259-5025021-0259-51 |
| Nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | Alembic Pharmaceuticals Limited | 46708-813 | 46708-0813-5046708-0813-63 |
| Nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | Alembic Pharmaceuticals Inc. | 62332-813 | 62332-0813-5062332-0813-63 |
| Nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-233 | 68083-0233-06 |
| Nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1743 | 70121-1743-0170121-1743-04 |
| nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | Shorla Oncology Inc. | 81927-111 | 81927-0111-0181927-0111-06 |
| Nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | Meitheal Pharmaceuticals Inc | 71288-165 | 71288-0165-54 |