Prescription drug · ANDA
Cladribine NDC 63323-140
Cladribine 1 mg/mL · Injection · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-140-10 | 63323014010 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-140-10) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 1, 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)
- Cladribine
- Generic name (nonproprietary)
- cladribine
- Active ingredients
- Cladribine — 1 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076571
- Marketing start
- Listing expires
- Identifiers
- Product ID 63323-140_77a36c8d-5dde-47a1-a50c-77239395cee2SPL ID 77a36c8d-5dde-47a1-a50c-77239395cee2SPL set ID a2592a9b-bca6-4a5a-89c2-855a0634d5feRxCUI 240754UNII 47M74X9YT5UPC 0363323140106
- Pharmacologic class
- Purine Antimetabolite
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
N463323014010followed by a unit qualifier and the quantityPackage 63323-0140-10. 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: Cladribine Injection, USP is indicated for the treatment of active Hairy Cell Leukemia as defined by clinically significant anemia, neutropenia, thrombocytopenia or disease-related symptoms.
Excerpt only. Read the full label for complete information.