Prescription drug · ANDA
Nelarabine NDC 68083-233
Nelarabine 5 mg/mL · Injection · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-233-06 | 6808302330668083023306 | 6 VIAL, SINGLE-DOSE in 1 CARTON (68083-233-06) / 50 mL in 1 VIAL, SINGLE-DOSE (68083-233-01)Marketed from Jan 3, 2024 |
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
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212605
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 68083-233_a8747c60-a869-4e8b-ad3a-270dfc118180SPL ID a8747c60-a869-4e8b-ad3a-270dfc118180SPL set ID 651bf4d2-75b0-4a60-8014-7006ffe61084RxCUI 603566UNII 60158CV180
- 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
N468083023306followed by a unit qualifier and the quantityPackage 68083-0233-06. 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 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 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.
Excerpt only. Read the full label for complete information.
About NDC 68083-233
- What is NDC 68083-233?
- 68083-233 is the product NDC for Nelarabine, Nelarabine 5 mg/mL injection, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, 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?
- Gland Pharma Limited, NDC labeler code 68083. 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 | 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 |
| Nelarabine | Nelarabine 5 mg/mL | InjectionIntravenous | Dr. Reddy's Laboratories, Inc. | 43598-142 | 43598-0142-0643598-0142-11 |
Other NDCs under ANDA 212605
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Nelarabine | Nelarabine 5 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-259 |