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Nelarabine 5 mg/mL Injection — NDC 70771-1685-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nelarabine 5 mg/mL Injection — NDC 70771-1685-8 (Billing 70771-1685-08)

by Zydus Lifesciences Limited · 6 VIAL in 1 CARTON / 50 mL in 1 VIAL

This is a package of Nelarabine 5 mg/mL Injection from Zydus Lifesciences Limited, marketed since Nov 2021 and currently FDA-listed.

NDC 70771-1685-08
🏷️ FDA NDC (as labeled) 70771-1685-8 billing pads the package segment with a zero
This package
Contains50 mL in 1 vial Pack sizes2 compare ↓
Product page 70771-1685-01 Also comes in: 50 mL 70771-1685-1
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 70771-1685-8 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70771 labeler · 1685 product · 8 package
Package marketed since
Nov 17, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7077116858 3
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Nelarabine (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 13, 2025 — Failed Impurities/Degradation Specifications (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0256-2025
Class II · Feb 13, 2025 — Failed Impurities/Degradation Specifications (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0255-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70771-1685-8
Product NDC 70771-1685
11-digit billing NDC 70771168508
RxCUI 603566
UNII 60158CV180
Application # ANDA215037
SPL Set ID 877b69a0-0899-455d-926e-f5a7478c31f8
Established class (EPC) Nucleoside Metabolic Inhibitor
Mechanism of action Nucleic Acid Synthesis Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-11-17
Route INTRAVENOUS
Dosage form INJECTION
Substance NELARABINE
TE code (Orange Book) AP · RLD · RS
Quick answers
  • RxCUI (RxNorm): 603566
Why two NDCs? The FDA registers this code as 70771-1685-8 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70771-1685-08. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Nucleoside Metabolic Inhibitor class.

Pharmacologic class Nucleoside Metabolic Inhibitor
Drug family (ATC) Purine analogues
How it works Nucleic Acid Synthesis Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Nelarabine is used to treat certain types of leukemia (cancer that begins in the white blood cells) and lymphoma (cancer that begins in the cells of the immune system) that have not improved or that have come back after treatment with other medications. Nelarabine is in a class of medications called antimetabolites. It works by killing cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Nelarabine (Arranon) is a chemotherapy used for two types of aggressive blood cancers: T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL). It's s...
  • Yes, absolutely. Nelarabine is given only by IV infusion in a clinical setting — it goes directly into a vein and has to be administered by trained healthcare professionals. You ca...
  • How will I receive this medication — will I need to go to a clinic?
  • The most important ones to act on right away are neurological — things like sudden severe drowsiness, confusion, seizures, muscle weakness, numbness or tingling that's getting wors...
📖 Read our full Nelarabine Injection guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 50 mL
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70771-1685-01 70771-1685-1 Main listing 1 VIAL in 1 CARTON / 50 mL in 1 VIAL 2021-11-17 — Active
70771-1685-08 You're viewing this 6 VIAL in 1 CARTON / 50 mL in 1 VIAL 2021-11-17 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 6 vial in 1 carton / 50 ml in 1 vial.
What NDC number is used to bill for this package of Nelarabine 5 mg/mL Injection?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Arranon 5 mg/mL 00078-0683-61 Novartis 50 ml — AP Discontinued —
Nelarabine 5 mg/mL 25021-0259-50 Sagent 1 vial — AP FDA listed —
Nelarabine 5 mg/mL 39822-0650-01 XGen 1 vial — AP FDA listed —
Nelarabine 5 mg/mL 43598-0142-06 Dr. 6 vials — AP FDA listed —
Nelarabine 5 mg/mL 46708-0813-50 Alembic 1 vial — AP FDA listed —
Nelarabine 5 mg/mL 62332-0813-50 Alembic 1 vial — AP FDA listed —
Arranon 5 mg/mL 66758-0165-94 Sandoz 1 vial — AP FDA listed —
Nelarabine 5 mg/mL 68083-0233-06 Gland 6 vials — AP FDA listed —
Nelarabine 5 mg/mL 70121-1743-04 Amneal 6 vials — AP FDA listed —
Nelarabine 5 mg/mL 70710-1726-01 Zydus 1 vial — AP FDA listed —
Nelarabine 5 mg/mL 70710-1839-01 Zydus 1 vial — AP FDA listed —
Nelarabine 5 mg/mLthis 70771-1685-08 Zydus 6 vials — AP FDA listed —
Nelarabine 5 mg/mL 71288-0165-53 Meitheal 6 vials — AP Discontinued —
Nelarabine 5 mg/mL 72205-0154-01 Novadoz 1 vial — AP FDA listed —
nelarabine 5 mg/mL 81927-0111-01 Shorla 1 vial — — FDA listed —
nelarabine 5 mg/mL 81927-0375-01 Shorla 1 vial — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2021
On the market since
Nov 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Nelarabine Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA215037 (ANDA)
Labeler code70771
First marketedNov 2021
Product typeHuman Prescription Drug
Portfolio720 products on file

More NDCs from Zydus Lifesciences Limited labeler code 70771

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 Package Label / Principal Display Panel
📄 Package Label / Principal Display Panel 45 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1685-1 Nelarabine Injection 250 mg/5 mL (5 mg/mL) 50 mL Single-Dose Vial For Intravenous Infusion Only Rx Only NDC 70771-1685-1 Nelarabine Injection 250 mg/5 mL (5 mg/mL) 50 mL Single-Dose Vial Carton For Intravenous Infusion Only Rx Only vial label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Zydus Lifesciences Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (70771-1685-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Zydus Lifesciences Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 70771-1684-06 · Zydus 70771-1687-03 · Zydus →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.