NDC codes

FDA NDC Directory
Product NDC (as listed)39822-0650Labeler and product segments. Claims need a package NDC.
Product NDC at billing width39822-0650Add 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 NDC11-digit (billing)PackageCopy
39822-0650-139822065001398220650011 VIAL in 1 CARTON (39822-0650-1) / 50 mL in 1 VIALMarketed from Feb 17, 2025
39822-0650-639822065006398220650066 VIAL in 1 CARTON (39822-0650-6) / 50 mL in 1 VIALMarketed from Feb 17, 2025

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
XGen Pharmaceuticals DJB, Inc.NDC labeler code 39822
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216510
Marketing start
Listing expires
Other FDA classes
Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers
Product ID 39822-0650_3b16087f-ced1-c8bc-e063-6294a90a51cbSPL ID 3b16087f-ced1-c8bc-e063-6294a90a51cb
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

N439822065001 followed by a unit qualifier and the quantity

Package 39822-0650-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 39822-0650

What is NDC 39822-0650?
39822-0650 is the product NDC for Nelarabine, Nelarabine 5 mg/mL injection, listed with the FDA by XGen Pharmaceuticals DJB, 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?
XGen Pharmaceuticals DJB, Inc., NDC labeler code 39822. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
nelarabineNelarabine 5 mg/mLInjectionIntravenousShorla Oncology Inc.81927-37581927-0375-01
NelarabineNelarabine 5 mg/mLInjectionIntravenousNovadoz Pharmaceuticals LLC72205-15472205-0154-0172205-0154-04
NelarabineNelarabine 5 mg/mLInjection, SolutionIntravenousSagent Pharmaceuticals25021-25925021-0259-5025021-0259-51
NelarabineNelarabine 5 mg/mLInjectionIntravenousAlembic Pharmaceuticals Limited46708-81346708-0813-5046708-0813-63
NelarabineNelarabine 5 mg/mLInjectionIntravenousAlembic Pharmaceuticals Inc.62332-81362332-0813-5062332-0813-63
NelarabineNelarabine 5 mg/mLInjectionIntravenousGland Pharma Limited68083-23368083-0233-06
NelarabineNelarabine 5 mg/mLInjectionIntravenousAmneal Pharmaceuticals LLC70121-174370121-1743-0170121-1743-04
nelarabineNelarabine 5 mg/mLInjectionIntravenousShorla Oncology Inc.81927-11181927-0111-0181927-0111-06
NelarabineNelarabine 5 mg/mLInjectionIntravenousMeitheal Pharmaceuticals Inc71288-16571288-0165-54
NelarabineNelarabine 5 mg/mLInjectionIntravenousDr. Reddy's Laboratories, Inc.43598-14243598-0142-0643598-0142-11

All 14 Nelarabine NDCs

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