Prescription drug · ANDA
Azathioprine NDC 68071-3772
Azathioprine 50 mg/1 · Tablet · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3772-6 | 6807137720668071377206 | 60 TABLET in 1 BOTTLE (68071-3772-6)Marketed from Jan 13, 2025 |
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.NDC labeler code 68071
- 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 68071-3772_2b9f91b9-795a-65e7-e063-6294a90a3680SPL ID 2b9f91b9-795a-65e7-e063-6294a90a3680SPL set ID 2b9f91b9-7959-65e7-e063-6294a90a3680RxCUI 197388UNII MRK240IY2LUPC 0368071377262
- 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
N468071377206followed by a unit qualifier and the quantityPackage 68071-3772-06. 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 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.
About NDC 68071-3772
- What is NDC 68071-3772?
- 68071-3772 is the product NDC for Azathioprine, Azathioprine 50 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Azathioprine.
- What is the active ingredient?
- Azathioprine.
- Who is the labeler?
- NuCare Pharmaceuticals, Inc., NDC labeler code 68071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Azathioprine?
- 28 other product NDCs are listed under this name. See all Azathioprine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Azathioprine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-835 | 16571-0835-01 |
| Azathioprine | Azathioprine 100 mg/1 | TabletOral | AvKARE | 42291-063 | 42291-0063-01 |
| Azathioprine | Azathioprine 75 mg/1 | TabletOral | Oceanside Pharmaceuticals | 68682-231 | 68682-0231-01 |
| Azathioprine | Azathioprine 100 mg/1 | TabletOral | Oceanside Pharmaceuticals | 68682-241 | 68682-0241-01 |
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3544 | 70518-3544-00 |
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | AvKARE | 42291-071 | 42291-0071-01 |
| Azathioprine | Azathioprine 75 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 60219-2036 | 60219-2036-01 |
| Azathioprine | Azathioprine 100 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 60219-2037 | 60219-2037-01 |
| Azathioprine | Azathioprine 25 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-492 | 67877-0492-0167877-0492-0567877-0492-10+2 more |
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-493 | 67877-0493-0167877-0493-0567877-0493-10+1 more |
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 50 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-602 |
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | American Health Packaging | 68084-229 |
| 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 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 |