NDC codes

FDA NDC Directory
Product NDC (as listed)61703-319Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61703-0319Add 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
61703-319-22617030319221 VIAL, SINGLE-DOSE in 1 CARTON (61703-319-22) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 22, 1999

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)
Cytarabine
Generic name (nonproprietary)
cytarabine
Active ingredients
Cytarabine — 100 mg/mL
Dosage form
Injection, Solution
Route
Intrathecal, Intravenous, Subcutaneous
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075383
Marketing start
Listing expires
Other FDA classes
Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers
Product ID 61703-319_3aa232be-a3c0-42d6-b959-c152c4136e65SPL ID 3aa232be-a3c0-42d6-b959-c152c4136e65SPL set ID 277597b0-7d85-40a3-a34a-70c6a883fc6dRxCUI 249364UNII 04079A1RDZ
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

N461703031922 followed by a unit qualifier and the quantity

Package 61703-0319-22. 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)

INDICATIONS AND USAGE Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075383

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

FDA NDC Directory listings under ANDA 075383
ProductStrengthForm · routeLabelerProduct NDC
CytarabineCytarabine 100 mg/mLInjection, SolutionIntrathecal, Intravenous, SubcutaneousHospira, Inc.61703-155

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