NDC codes

FDA NDC Directory
Product NDC (as listed)70377-057Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70377-0057Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70377-057-11703770057117037700571130 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

N470377005711 followed by a unit qualifier and the quantity

Package 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.

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