Prescription drug · ANDA
Azathioprine NDC 51407-182
Azathioprine 50 mg/1 · Tablet · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-182-01 | 5140701820151407018201 | 100 TABLET in 1 BOTTLE (51407-182-01)Marketed from Dec 7, 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
- Labeler
- Golden State Medical Supply, Inc.NDC labeler code 51407
- 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 51407-182_2bb2bd7b-18fd-1821-e063-6294a90a5c0eSPL ID 2bb2bd7b-18fd-1821-e063-6294a90a5c0eSPL set ID 8429e025-b79d-dae7-e053-2a91aa0a7fe5RxCUI 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
N451407018201followed by a unit qualifier and the quantityPackage 51407-0182-01. 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 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 Tablets on these variables has not been tested in controlled trials. Rheumatoid Arthriti…
Excerpt only. Read the full label for complete information.
About NDC 51407-182
- What is NDC 51407-182?
- 51407-182 is the product NDC for Azathioprine, Azathioprine 50 mg/1 tablet, listed with the FDA by Golden State Medical Supply, 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?
- Golden State Medical Supply, Inc., NDC labeler code 51407. 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 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 | Glenmark Pharmaceuticals, Inc | 68462-502 |
| Azathioprine | Azathioprine 75 mg/1 | TabletOral | Oceanside Pharmaceuticals | 68682-231 |
| Azathioprine | Azathioprine 100 mg/1 | TabletOral | Oceanside Pharmaceuticals | 68682-241 |