Prescription drug · ANDA
Azathioprine NDC 68071-3997
Azathioprine 50 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3997-6 | 68071399706 | 60 TABLET in 1 BOTTLE (68071-3997-6)Marketed from May 5, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Azathioprine
- Generic name (nonproprietary)
- azathioprine
- Active ingredients
- Azathioprine — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208687
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)Nucleosides (Chemical structure)Purines (Chemical structure)
- Identifiers
- Product ID 68071-3997_5116b232-1893-9012-e063-6294a90a06f6SPL ID 5116b232-1893-9012-e063-6294a90a06f6SPL set ID 5116b22b-1460-5535-e063-6394a90acbe5RxCUI 197388UNII MRK240IY2L
- 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
N468071399706followed by a unit qualifier and the quantityPackage 68071-3997-06. 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 & USAGE Azathioprine 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: Azathioprine 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 azathioprine on these variables has not been tested in controlled trials. Rheumatoid Arthritis: Azathioprine is indicated …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208687
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 25 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-492 |
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-493 |
| Azathioprine | Azathioprine 75 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-494 |
| Azathioprine | Azathioprine 100 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-495 |
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3544 |