What is NDC 70771-1685?

70771-1685 is the product NDC for Nelarabine, Nelarabine 5 mg/mL injection, listed with the FDA by Zydus Lifesciences Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Zydus Lifesciences Limited, NDC labeler code 70771. 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 70771-1685 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1685Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1685Add 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
70771-1685-1	7077116850170771168501	1 VIAL in 1 CARTON (70771-1685-1) / 50 mL in 1 VIALMarketed from Nov 17, 2021
70771-1685-8	7077116850870771168508	6 VIAL in 1 CARTON (70771-1685-8) / 50 mL in 1 VIALMarketed from Nov 17, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Zydus Lifesciences LimitedNDC labeler code 70771
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215037
Marketing start: Nov 17, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 70771-1685_d96809f2-f942-4f6d-92b9-0a23ec84226dSPL ID d96809f2-f942-4f6d-92b9-0a23ec84226dSPL set ID 877b69a0-0899-455d-926e-f5a7478c31f8RxCUI 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

N470771168501 followed by a unit qualifier and the quantity

Package 70771-1685-01. 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 Nov 5, 2022.

Full label on DailyMed (opens in a new tab)

About NDC 70771-1685

What is NDC 70771-1685?: 70771-1685 is the product NDC for Nelarabine, Nelarabine 5 mg/mL injection, listed with the FDA by Zydus Lifesciences 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?: Zydus Lifesciences Limited, NDC labeler code 70771. 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 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

All 14 Nelarabine NDCs

Other NDCs under ANDA 215037

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

FDA NDC Directory listings under ANDA 215037
Product	Strength	Form · route	Labeler	Product NDC
Nelarabine	Nelarabine 5 mg/mL	InjectionIntravenous	Zydus Pharmaceuticals USA Inc.	70710-1726
Nelarabine	Nelarabine 5 mg/mL	InjectionIntravenous	Zydus Pharmaceuticals USA Inc.	70710-1839