NDC codes

FDA NDC Directory
Product NDC (as listed)72865-366Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72865-0366Add 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
72865-366-127286503661272865036612120 TABLET, FILM COATED in 1 BOTTLE (72865-366-12)Marketed from Oct 9, 2026
72865-366-60728650366607286503666060 TABLET, FILM COATED in 1 BOTTLE (72865-366-60)Marketed from Oct 9, 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 — 5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
XLCare Pharmaceuticals IncNDC labeler code 72865
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 219530
Marketing start
Listing expires
Other FDA classes
Janus Kinase Inhibitors (Mechanism)
Identifiers
Product ID 72865-366_10403307-e2f9-44d1-bc72-552fdba299d1SPL ID 10403307-e2f9-44d1-bc72-552fdba299d1
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

N472865036612 followed by a unit qualifier and the quantity

Package 72865-0366-12. 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 72865-366

What is NDC 72865-366?
72865-366 is the product NDC for Tofacitinib, Tofacitinib citrate 5 mg/1 tablet, film coated, listed with the FDA by XLCare Pharmaceuticals Inc. 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?
XLCare Pharmaceuticals Inc, NDC labeler code 72865. 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?
38 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tofacitinib NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TofacitinibTofacitinib citrate 10 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc72865-36772865-0367-1272865-0367-60
TofacitinibTofacitinib citrate 5 mg/1Tablet, Film coatedOralAvKARE73190-10073190-0100-60
TofacitinibTofacitinib citrate 10 mg/1Tablet, Film coatedOralAvKARE73190-10173190-0101-60
TofacitinibTofacitinib citrate 11 mg/1Tablet, Film coated, Extended releaseOralAvKARE73190-10273190-0102-30
TofacitinibTofacitinib citrate 1 mg/mLSolutionOralIPG Pharmaceuticals, Inc71085-09971085-0099-24
TofacitinibTofacitinib citrate 11 mg/1Tablet, Film coated, Extended releaseOralExelan pharmaceuticals,Inc76282-81676282-0816-30
TofacitinibTofacitinib citrate 11 mg/1Tablet, Film coated, Extended releaseOralOrient Pharma Co., Ltd. Yunlin Plant76333-11176333-0111-15
TofacitinibTofacitinib citrate 10 mg/1Tablet, Film coatedOralMicro Labs Limited42571-37742571-0377-0542571-0377-3042571-0377-60+1 more
tofacitinibTofacitinib citrate 10 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.70710-158970710-1589-0670710-1589-0770710-1589-08
tofacitinibTofacitinib citrate 10 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-196770771-1967-0670771-1967-0770771-1967-08

All 39 Tofacitinib NDCs

Other NDCs under ANDA 219530

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 219530
ProductStrengthForm · routeLabelerProduct NDC
TofacitinibTofacitinib citrate 5 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-541
TofacitinibTofacitinib citrate 10 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-542
TofacitinibTofacitinib citrate 10 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc72865-367

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