Prescription drug · ANDA
Azathioprine NDC 70518-3544
Azathioprine 50 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3544-0 | 70518354400 | 100 POUCH in 1 BOX (70518-3544-0) / 1 TABLET in 1 POUCH (70518-3544-1)Marketed from Sep 30, 2022 |
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
- REMEDYREPACK INC.NDC labeler code 70518
- 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 70518-3544_4f58b212-db57-4132-e063-6394a90a1cdfSPL ID 4f58b212-db57-4132-e063-6394a90a1cdfSPL set ID f251f372-c881-483e-8035-c6a8a6bfb4e8RxCUI 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
N470518354400followed by a unit qualifier and the quantityPackage 70518-3544-00. 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.
About NDC 70518-3544
- What is NDC 70518-3544?
- 70518-3544 is the product NDC for Azathioprine, Azathioprine 50 mg/1 tablet, listed with the FDA by REMEDYREPACK 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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 | 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 75 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-494 | 67877-0494-0167877-0494-0567877-0494-10+1 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 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 75 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-494 |
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-493 |
| Azathioprine | Azathioprine 100 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-495 |
| Azathioprine | Azathioprine 50 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3997 |