Prescription drug · ANDA
Tofacitinib NDC 42571-377
Tofacitinib citrate 10 mg/1 · Tablet, Film coated · Oral · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-377-05 | 42571037705 | 500 TABLET, FILM COATED in 1 BOTTLE (42571-377-05)Marketed from Jun 8, 2026 | |
| 42571-377-30 | 42571037730 | 30 TABLET, FILM COATED in 1 BOTTLE (42571-377-30)Marketed from Jun 8, 2026 | |
| 42571-377-60 | 42571037760 | 60 TABLET, FILM COATED in 1 BOTTLE (42571-377-60)Marketed from Jun 8, 2026 | |
| 42571-377-76 | 42571037776 | 150 BLISTER PACK in 1 CARTON (42571-377-76) / 15 TABLET, FILM COATED in 1 BLISTER PACK (42571-377-13)Marketed from Jun 8, 2026 |
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)
- Tofacitinib
- Generic name (nonproprietary)
- tofacitinib
- Active ingredients
- Tofacitinib citrate — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Micro Labs Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209738
- Marketing start
- Listing expires
- Other FDA classes
- Janus Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 42571-377_5bbcede4-b96e-ff33-e063-6294a90a9a82SPL ID 5bbcede4-b96e-ff33-e063-6294a90a9a82
- Pharmacologic class
- Janus Kinase 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 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
N442571037705followed by a unit qualifier and the quantityPackage 42571-0377-05. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 209738
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 |
|---|---|---|---|---|
| Tofacitinib | Tofacitinib citrate 5 mg/1 | Tablet, Film coatedOral | Micro Labs Limited | 42571-268 |