Prescription drug · ANDA
Tofacitinib XR (Tofacitinib) NDC 70377-057
Tofacitinib citrate 11 mg/1 · Tablet, Film coated, Extended release · Oral · Biocon Pharma Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70377-057-11 | 7037700571170377005711 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70377-057-11)Marketed from Jun 3, 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 XRSuffix: XR
- Generic name (nonproprietary)
- tofacitinib
- Active ingredients
- Tofacitinib citrate — 11 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Biocon Pharma IncNDC labeler code 70377
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219442
- Marketing start
- Listing expires
- Other FDA classes
- Janus Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 70377-057_93a2a5ce-b75f-77df-ec07-ccc1b238e0d7SPL ID 93a2a5ce-b75f-77df-ec07-ccc1b238e0d7
- 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
N470377005711followed by a unit qualifier and the quantityPackage 70377-0057-11. 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 70377-057
- What is NDC 70377-057?
- 70377-057 is the product NDC for Tofacitinib XR (tofacitinib), Tofacitinib citrate 11 mg/1 tablet, film coated, extended release, listed with the FDA by Biocon Pharma Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tofacitinib XR (Tofacitinib).
- What is the active ingredient?
- Tofacitinib citrate.
- Who is the labeler?
- Biocon Pharma Inc, NDC labeler code 70377. 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 XR?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.