Prescription drug · ANDA
Cladribine NDC 0781-8201
Cladribine 10 mg/1 · Tablet · Oral · Sandoz Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-8201-37 | 00781820137 | 9 TABLET in 1 CARTON (0781-8201-37)Marketed from Apr 29, 2026 | |
| 0781-8201-51 | 00781820151 | 5 TABLET in 1 CARTON (0781-8201-51)Marketed from Apr 29, 2026 | |
| 0781-8201-68 | 00781820168 | 6 TABLET in 1 CARTON (0781-8201-68)Marketed from Apr 29, 2026 | |
| 0781-8201-71 | 00781820171 | 7 TABLET in 1 CARTON (0781-8201-71)Marketed from Apr 29, 2026 | |
| 0781-8201-80 | 00781820180 | 10 TABLET in 1 CARTON (0781-8201-80)Marketed from Apr 29, 2026 | |
| 0781-8201-85 | 00781820185 | 8 TABLET in 1 CARTON (0781-8201-85)Marketed from Apr 29, 2026 | |
| 0781-8201-94 | 00781820194 | 4 TABLET in 1 CARTON (0781-8201-94)Marketed from Apr 29, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Sandoz Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215547
- Marketing start
- Listing expires
- Identifiers
- Product ID 0781-8201_549c44bf-67d2-9e14-e063-6294a90a9097SPL ID 549c44bf-67d2-9e14-e063-6294a90a9097SPL set ID e0b363cb-db83-44d6-89d0-1f7176be7459RxCUI 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
N400781820137followed by a unit qualifier and the quantityPackage 00781-8201-37. 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 is 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 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) ]. Cladribine is a purine antimetabolite 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 is generally recommend…
Excerpt only. Read the full label for complete information.