NDC codes

FDA NDC Directory
Product NDC (as listed)77771-567Labeler and product segments. Claims need a package NDC.
Product NDC at billing width77771-0567Add 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
77771-567-30777710567307777105673030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (77771-567-30)Marketed from Jul 14, 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 Citrate
Generic name (nonproprietary)
tofacitinib citrate
Active ingredients
Tofacitinib citrate — 11 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Radha Pharmaceuticals, Inc.NDC labeler code 77771
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 220972
Marketing start
Listing expires
Other FDA classes
Janus Kinase Inhibitors (Mechanism)
Identifiers
Product ID 77771-567_12039792-2d83-46ac-be82-fdbd00191024SPL ID 12039792-2d83-46ac-be82-fdbd00191024SPL set ID 141ab3eb-982b-4242-89db-6ddce5be0c40RxCUI 1741046UNII O1FF4DIV0DUPC 0377771567309
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

N477771056730 followed by a unit qualifier and the quantity

Package 77771-0567-30. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Tofacitinib extended-release tablets are Janus kinase (JAK) inhibitors. Tofacitinib extended-release tablets are indicated for the treatment of adult patients with: Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers. Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers. Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use: Use of tofaci…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 77771-567

What is NDC 77771-567?
77771-567 is the product NDC for Tofacitinib Citrate, Tofacitinib citrate 11 mg/1 tablet, film coated, extended release, listed with the FDA by Radha Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tofacitinib Citrate.
What is the active ingredient?
Tofacitinib citrate.
Who is the labeler?
Radha Pharmaceuticals, Inc., NDC labeler code 77771. 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 Citrate?
4 other product NDCs are listed under this name. See all Tofacitinib Citrate 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 Citrate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Tofacitinib CitrateTofacitinib citrate 8.08 mg/1Tablet, Film coatedOralStellon Biotech Inc.85972-12185972-0121-60
Tofacitinib CitrateTofacitinib citrate 16.16 mg/1Tablet, Film coatedOralStellon Biotech Inc.85972-12285972-0122-60
Tofacitinib CitrateTofacitinib citrate 11 mg/1Tablet, Film coated, Extended releaseOralScieGen Pharmaceuticals, INC.50228-56750228-0567-1050228-0567-30
Tofacitinib CitrateTofacitinib citrate 11 mg/1Tablet, Film coated, Extended releaseOralPadagis US LLC0574-181100574-1811-30

Other NDCs under ANDA 220972

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

FDA NDC Directory listings under ANDA 220972
ProductStrengthForm · routeLabelerProduct NDC
Tofacitinib CitrateTofacitinib citrate 11 mg/1Tablet, Film coated, Extended releaseOralScieGen Pharmaceuticals, INC.50228-567

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