NDC codes

FDA NDC Directory
Product NDC (as listed)81927-111Labeler and product segments. Claims need a package NDC.
Product NDC at billing width81927-0111Add 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
81927-111-0181927011101819270111011 VIAL, SINGLE-DOSE in 1 CARTON (81927-111-01) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 15, 2023
81927-111-0681927011106819270111066 VIAL, SINGLE-DOSE in 1 CARTON (81927-111-06) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 15, 2023

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
Shorla Oncology Inc.NDC labeler code 81927
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214809
Marketing start
Listing expires
Other FDA classes
Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers
Product ID 81927-111_f21b358e-9f41-4dc3-858f-b55f9a8af715SPL ID f21b358e-9f41-4dc3-858f-b55f9a8af715SPL set ID fc401b06-4e3b-413e-a854-3e031c433862RxCUI 603566, 2722411UNII 60158CV180UPC 0381927111018
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

N481927011101 followed by a unit qualifier and the quantity

Package 81927-0111-01. 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 . 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 2 chemotherapy regimens. Nelarabine Injection 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. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 81927-111

What is NDC 81927-111?
81927-111 is the product NDC for nelarabine, Nelarabine 5 mg/mL injection, listed with the FDA by Shorla Oncology 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?
Shorla Oncology Inc., NDC labeler code 81927. 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/mLInjectionIntravenousXGen Pharmaceuticals DJB, Inc.39822-065039822-0650-0139822-0650-06
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/mLInjectionIntravenousMeitheal Pharmaceuticals Inc71288-16571288-0165-54
NelarabineNelarabine 5 mg/mLInjectionIntravenousDr. Reddy's Laboratories, Inc.43598-14243598-0142-0643598-0142-11

All 14 nelarabine NDCs

Other NDCs under ANDA 214809

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

FDA NDC Directory listings under ANDA 214809
ProductStrengthForm · routeLabelerProduct NDC
nelarabineNelarabine 5 mg/mLInjectionIntravenousShorla Oncology Inc.81927-375

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