Prescription drug · ANDA
tofacitinib NDC 70771-1627
Tofacitinib citrate 11 mg/1 · Tablet, Film coated, Extended release · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1627-3 | 7077116270370771162703 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1627-3)Marketed from May 20, 2026 | |
| 70771-1627-9 | 7077116270970771162709 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1627-9)Marketed from May 20, 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 — 11 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214264
- Marketing start
- Listing expires
- Other FDA classes
- Janus Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 70771-1627_8997ddda-2a43-45c8-98b0-f1ac03fa3d09SPL ID 8997ddda-2a43-45c8-98b0-f1ac03fa3d09SPL set ID ac0b26d5-1352-42ff-b5ea-3eb02d8508a4RxCUI 1741046, 2273113UNII O1FF4DIV0DUPC 0370710172732, 0370710135331
- 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
N470771162703followed by a unit qualifier and the quantityPackage 70771-1627-03. 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 .
About NDC 70771-1627
- What is NDC 70771-1627?
- 70771-1627 is the product NDC for tofacitinib, Tofacitinib citrate 11 mg/1 tablet, film coated, extended release, listed with the FDA by Zydus Lifesciences Limited. It has 2 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 Lifesciences Limited, NDC labeler code 70771. 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 214264
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 11 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-1353 |
| tofacitinib | Tofacitinib citrate 22 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-1727 |
| tofacitinib | Tofacitinib citrate 22 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 70771-1628 |