Prescription drug · ANDA
Cytarabine NDC 63323-120
Cytarabine 100 mg/mL · Injection, Solution · Intrathecal, Intravenous, Subcutaneous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-120-20 | 63323012020 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-120-20) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 29, 2004 |
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
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076512
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 63323-120_88adbc49-b19d-44af-8f0b-a563bbb02aecSPL ID 88adbc49-b19d-44af-8f0b-a563bbb02aecSPL set ID c4fdc56e-efd7-4825-a518-ef430b2b3df0RxCUI 249364UNII 04079A1RDZUPC 0363323120207
- 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
N463323012020followed by a unit qualifier and the quantityPackage 63323-0120-20. 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 non-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.