Prescription drug · ANDA
Cladribine NDC 60505-4791
Cladribine 10 mg/1 · Tablet · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-4791-1 | 60505479101 | 10 TABLET in 1 CARTON (60505-4791-1)Marketed from Nov 25, 2025 | |
| 60505-4791-4 | 60505479104 | 4 TABLET in 1 CARTON (60505-4791-4)Marketed from Nov 25, 2025 | |
| 60505-4791-5 | 60505479105 | 5 TABLET in 1 CARTON (60505-4791-5)Marketed from Nov 25, 2025 | |
| 60505-4791-6 | 60505479106 | 6 TABLET in 1 CARTON (60505-4791-6)Marketed from Nov 25, 2025 | |
| 60505-4791-7 | 60505479107 | 7 TABLET in 1 CARTON (60505-4791-7)Marketed from Nov 25, 2025 | |
| 60505-4791-8 | 60505479108 | 8 TABLET in 1 CARTON (60505-4791-8)Marketed from Nov 25, 2025 | |
| 60505-4791-9 | 60505479109 | 9 TABLET in 1 CARTON (60505-4791-9)Marketed from Nov 25, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Apotex Corp.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218425
- Marketing start
- Listing expires
- Identifiers
- Product ID 60505-4791_34340d61-039c-2b08-23a6-e3a2389f10a2SPL ID 34340d61-039c-2b08-23a6-e3a2389f10a2SPL set ID 407c52d5-6498-7da5-da35-acc9ca73ced3RxCUI 2122634, 2122635, 2122647, 2122649, 2122654, 2122656, 2122658, 2122660UNII 47M74X9YT5
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N460505479101followed by a unit qualifier and the quantityPackage 60505-4791-01. 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)
Cladribine tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease in adults. Because of its safety profile, use of cladribine tablets is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS [ see Warnings and Precautions (5) ]. Limitations of Use Cladribine tablets are not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile [ see Warnings and Precautions (5) ]. Cladribine tablets are purine antimetabolite indicated for the treatment …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218425
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cladribine | Cladribine 10 mg/1 | TabletOral | Genvion Corporation | 62049-286 |