Prescription drug · ANDA
Azasan (azathioprine) NDC 65649-231
Azathioprine 75 mg/1 · Tablet · Oral · Salix Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65649-231-41 | 65649023141 | 100 TABLET in 1 BOTTLE (65649-231-41)Marketed from Apr 1, 2003 |
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)
- Azasan
- Generic name (nonproprietary)
- azathioprine
- Active ingredients
- Azathioprine — 75 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Salix Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075252
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)Nucleosides (Chemical structure)Purines (Chemical structure)
- Identifiers
- Product ID 65649-231_85aaaf8a-26bf-4878-9356-490f17fe65efSPL ID 85aaaf8a-26bf-4878-9356-490f17fe65efSPL set ID 9050af7a-19c6-4670-937a-9445605de995RxCUI 359228, 359229, 404475, 404476UNII MRK240IY2LUPC 0365649231414
- 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
N465649023141followed by a unit qualifier and the quantityPackage 65649-0231-41. 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: AZASAN 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: AZASAN 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 AZASAN on these variables has not been tested in controlled trials. Rheumatoid Arthritis: AZASAN is indicated for the treatment of …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075252
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 |
|---|---|---|---|---|
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | Glenmark Pharmaceuticals, Inc | 68462-502 |
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-182 |
| Azasanazathioprine | Azathioprine 100 mg/1 | TabletOral | Salix Pharmaceuticals | 65649-241 |
| Azathioprine | Azathioprine 75 mg/1 | TabletOral | Oceanside Pharmaceuticals | 68682-231 |
| Azathioprine | Azathioprine 100 mg/1 | TabletOral | Oceanside Pharmaceuticals | 68682-241 |