What is NDC 46708-813?

46708-813 is the product NDC for Nelarabine, Nelarabine 5 mg/mL injection, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nelarabine NDC 46708-813 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-813Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0813Add 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
46708-813-50	4670808135046708081350	1 VIAL in 1 CARTON (46708-813-50) / 50 mL in 1 VIALMarketed from Aug 1, 2024
46708-813-63	4670808136346708081363	6 VIAL in 1 CARTON (46708-813-63) / 50 mL in 1 VIALMarketed from Aug 1, 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: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218554
Marketing start: Aug 1, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 46708-813_482d7978-12a5-467a-b10e-1789df5dd0f8SPL ID 482d7978-12a5-467a-b10e-1789df5dd0f8SPL set ID 03ad6056-0e71-4e7c-842a-a5f87649bdcdRxCUI 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.

How CPT relates to drug billing

NDC on a medical claim

N446708081350 followed by a unit qualifier and the quantity

Package 46708-0813-50. 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 7, 2024. 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 two chemotherapy regimens. Nelarabine injection is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma 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.

Full label on DailyMed (opens in a new tab)

About NDC 46708-813

What is NDC 46708-813?: 46708-813 is the product NDC for Nelarabine, Nelarabine 5 mg/mL injection, listed with the FDA by Alembic Pharmaceuticals Limited. 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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.

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

Other Nelarabine NDCs
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 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
Nelarabine	Nelarabine 5 mg/mL	InjectionIntravenous	Dr. Reddy's Laboratories, Inc.	43598-142	43598-0142-0643598-0142-11

All 14 Nelarabine NDCs

Other NDCs under ANDA 218554

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

FDA NDC Directory listings under ANDA 218554
Product	Strength	Form · route	Labeler	Product NDC
Nelarabine	Nelarabine 5 mg/mL	InjectionIntravenous	Alembic Pharmaceuticals Inc.	62332-813