Prescription drug · NDA
Imuran (Azathioprine) NDC 54766-590
Azathioprine 50 mg/1 · Tablet · Oral · Sebela Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54766-590-10 | 5476605901054766059010 | 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.NDC labeler code 54766
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 016324
- Marketing start
- Marketing end
- 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
N454766059010followed by a unit qualifier and the quantityPackage 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 . 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.
About NDC 54766-590
- What is NDC 54766-590?
- 54766-590 is the product NDC for Imuran (azathioprine), Azathioprine 50 mg/1 tablet, listed with the FDA by Sebela Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Imuran (Azathioprine).
- What is the active ingredient?
- Azathioprine.
- Who is the labeler?
- Sebela Pharmaceuticals Inc., NDC labeler code 54766. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Imuran?
- 1 other product NDC are listed under this name. See all Imuran NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Imuran products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Imuranazathioprine | Azathioprine 50 mg/1 | TabletOral | Legacy Pharma USA Inc. | 83107-025 | 83107-0025-10 |
Other NDCs under NDA 016324
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Imuranazathioprine | Azathioprine 50 mg/1 | TabletOral | Legacy Pharma USA Inc. | 83107-025 |