Prescription drug · ANDA
Cytarabine NDC 71288-109
Cytarabine 2 g/20mL · Injection, Solution · Intrathecal, Intravenous, Subcutaneous · Meitheal Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71288-109-20 | 71288010920 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-109-20) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 17, 2018 |
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 — 2 g/20mL
- Dosage form
- Injection, Solution
- Route
- Intrathecal, Intravenous, Subcutaneous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205696
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 71288-109_695b376b-3972-4aef-b003-f1fb6fcde5b7SPL ID 695b376b-3972-4aef-b003-f1fb6fcde5b7SPL set ID 8105e590-fc7e-45b7-9604-c2d0d1be5eacRxCUI 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.
- NDC on a medical claim
N471288010920followed by a unit qualifier and the quantityPackage 71288-0109-20. 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.