Imuran (azathioprine) NDC 54766-590

NDC codes

FDA NDC Directory

Product NDC (as listed)54766-590Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54766-0590Add 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 NDC	11-digit (billing)	Package	Copy
54766-590-10	54766059010	100 TABLET in 1 BOTTLE (54766-590-10)Marketed from Dec 1, 2017

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): Imuran
Generic name (nonproprietary): azathioprine
Active ingredients: Azathioprine — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Sebela Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 016324
Marketing start: Dec 1, 2017
Marketing end: Apr 30, 2028
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)Nucleosides (Chemical structure)Purines (Chemical structure)
Identifiers: Product ID 54766-590_431426e8-80d4-a4e2-e063-6394a90af918SPL ID 431426e8-80d4-a4e2-e063-6394a90af918SPL set ID 606101a0-6244-7eff-e053-2a91aa0acaddRxCUI 105611, 197388UNII MRK240IY2LUPC 0354766590108
Pharmacologic class: Purine Antimetabolite

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

N454766059010 followed by a unit qualifier and the quantity

Package 54766-0590-10. 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 Nov 8, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE: IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Renal Homotransplantation: IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of IMURAN on these variables has not been tested in controlled trials. Rheumatoid Arthritis: IMURAN is indicated for the treatment of …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 016324

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

FDA NDC Directory listings under NDA 016324
Product	Strength	Form · route	Labeler	Product NDC
Imuranazathioprine	Azathioprine 50 mg/1	TabletOral	Legacy Pharma USA Inc.	83107-025