Prescription drug · ANDA
tofacitinib NDC 70710-1589
Tofacitinib citrate 10 mg/1 · Tablet, Film coated · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1589-6 | 7071015890670710158906 | 60 TABLET, FILM COATED in 1 BOTTLE (70710-1589-6)Marketed from Jun 5, 2026 | |
| 70710-1589-7 | 7071015890770710158907 | 28 TABLET, FILM COATED in 1 BOTTLE (70710-1589-7)Marketed from Jun 5, 2026 | |
| 70710-1589-8 | 7071015890870710158908 | 180 TABLET, FILM COATED in 1 BOTTLE (70710-1589-8)Marketed from Jun 5, 2026 |
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)
- tofacitinib
- Generic name (nonproprietary)
- tofacitinib
- Active ingredients
- Tofacitinib citrate — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Zydus Pharmaceuticals USA Inc.NDC labeler code 70710
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209829
- Marketing start
- Listing expires
- Other FDA classes
- Janus Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 70710-1589_cc64537d-8d39-435b-98a8-905780825baaSPL ID cc64537d-8d39-435b-98a8-905780825baa
- 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
N470710158906followed by a unit qualifier and the quantityPackage 70710-1589-06. 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.
About NDC 70710-1589
- What is NDC 70710-1589?
- 70710-1589 is the product NDC for tofacitinib, Tofacitinib citrate 10 mg/1 tablet, film coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- tofacitinib.
- What is the active ingredient?
- Tofacitinib citrate.
- Who is the labeler?
- Zydus Pharmaceuticals USA Inc., NDC labeler code 70710. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for tofacitinib?
- 39 other product NDCs are listed under this name. See all tofacitinib NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other tofacitinib products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tofacitinib | Tofacitinib citrate 5 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc | 72865-366 | 72865-0366-1272865-0366-60 |
| Tofacitinib | Tofacitinib citrate 10 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc | 72865-367 | 72865-0367-1272865-0367-60 |
| Tofacitinib | Tofacitinib citrate 1 mg/mL | SolutionOral | Saptalis Pharmaceuticals, LLC. | 71656-071 | — |
| Tofacitinib | Tofacitinib citrate 5 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-100 | 73190-0100-60 |
| Tofacitinib | Tofacitinib citrate 10 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-101 | 73190-0101-60 |
| Tofacitinib | Tofacitinib citrate 11 mg/1 | Tablet, Film coated, Extended releaseOral | AvKARE | 73190-102 | 73190-0102-30 |
| Tofacitinib | Tofacitinib citrate 1 mg/mL | SolutionOral | IPG Pharmaceuticals, Inc | 71085-099 | 71085-0099-24 |
| Tofacitinib | Tofacitinib citrate 11 mg/1 | Tablet, Film coated, Extended releaseOral | Exelan pharmaceuticals,Inc | 76282-816 | 76282-0816-30 |
| Tofacitinib | Tofacitinib citrate 11 mg/1 | Tablet, Film coated, Extended releaseOral | Orient Pharma Co., Ltd. Yunlin Plant | 76333-111 | 76333-0111-15 |
| Tofacitinib | Tofacitinib citrate 10 mg/1 | Tablet, Film coatedOral | Micro Labs Limited | 42571-377 | 42571-0377-0542571-0377-3042571-0377-60+1 more |
Other NDCs under ANDA 209829
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 | Zydus Pharmaceuticals USA Inc. | 70710-1243 |
| tofacitinib | Tofacitinib citrate 5 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1821 |
| tofacitinib | Tofacitinib citrate 10 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1967 |