Prescription drug · ANDA
Azathioprine NDC 68682-241
Azathioprine 100 mg/1 · Tablet · Oral · Oceanside Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68682-241-01 | 6868202410168682024101 | 100 TABLET in 1 BOTTLE (68682-241-01)Marketed from Feb 4, 2023 |
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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Oceanside PharmaceuticalsNDC labeler code 68682
- 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 68682-241_72e365c2-ab18-4c84-8252-d5287ceeb95fSPL ID 72e365c2-ab18-4c84-8252-d5287ceeb95fSPL set ID d72ede2c-1a9b-4717-80a7-b76a6a499936RxCUI 359228, 359229UNII 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
N468682024101followed by a unit qualifier and the quantityPackage 68682-0241-01. 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 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 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: Azathioprine T…
Excerpt only. Read the full label for complete information.
About NDC 68682-241
- What is NDC 68682-241?
- 68682-241 is the product NDC for Azathioprine, Azathioprine 100 mg/1 tablet, listed with the FDA by Oceanside Pharmaceuticals. 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?
- Oceanside Pharmaceuticals, NDC labeler code 68682. 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 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 |
| Azathioprine | Azathioprine 75 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-494 | 67877-0494-0167877-0494-0567877-0494-10+1 more |
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 |
|---|---|---|---|---|
| Azasanazathioprine | Azathioprine 75 mg/1 | TabletOral | Salix Pharmaceuticals | 65649-231 |
| Azasanazathioprine | Azathioprine 100 mg/1 | TabletOral | Salix Pharmaceuticals | 65649-241 |
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-182 |
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | Glenmark Pharmaceuticals, Inc | 68462-502 |
| Azathioprine | Azathioprine 75 mg/1 | TabletOral | Oceanside Pharmaceuticals | 68682-231 |