Prescription drug · ANDA
Azathioprine NDC 68084-229
Azathioprine 50 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-229-01 | 68084022901 | 100 BLISTER PACK in 1 CARTON (68084-229-01) / 1 TABLET in 1 BLISTER PACK (68084-229-11)Marketed from Feb 22, 2008 |
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
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077621
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)Nucleosides (Chemical structure)Purines (Chemical structure)
- Identifiers
- Product ID 68084-229_3582bd73-c190-955e-e063-6394a90a634fSPL ID 3582bd73-c190-955e-e063-6394a90a634fSPL set ID 040d010a-b1b2-4db7-905d-8aa7f1bab0cdRxCUI 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
N468084022901followed by a unit qualifier and the quantityPackage 68084-0229-01. 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, USP 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, USP 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 tablets on these variables has not been tested in controlled trials. Rheumatoid …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077621
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 | Zydus Lifesciences Limited | 70771-1139 |
| Azathioprine | Azathioprine 75 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1140 |
| Azathioprine | Azathioprine 100 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1141 |
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-003 |
| Azathioprine | Azathioprine 25 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-118 |
| Azathioprine | Azathioprine 75 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-119 |
| Azathioprine | Azathioprine 100 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-120 |
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3772 |
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-602 |