Prescription drug · ANDA
Azathioprine NDC 71610-124
Azathioprine 50 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-124-09 | 71610012409 | 9000 TABLET in 1 BOTTLE (71610-124-09)Marketed from Aug 17, 2018 |
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)
- Azathioprine
- Generic name (nonproprietary)
- azathioprine
- Active ingredients
- Azathioprine — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074069
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)Nucleosides (Chemical structure)Purines (Chemical structure)
- Identifiers
- Product ID 71610-124_3bd2577b-8447-4b76-b7f2-aeefbf8abac0SPL ID 3bd2577b-8447-4b76-b7f2-aeefbf8abac0SPL set ID 2f994aed-f8e7-4967-a167-b22b783b4192RxCUI 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
N471610012409followed by a unit qualifier and the quantityPackage 71610-0124-09. 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 Azathioprine tablets are 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 tablets are 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 : Aza…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074069
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 100 mg/1 | TabletOral | AvKARE | 42291-063 |
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | AvKARE | 42291-071 |
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 60219-1076 |
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-1076 |
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-129 |
| Azathioprine | Azathioprine 75 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 60219-2036 |
| Azathioprine | Azathioprine 100 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 60219-2037 |