Prescription drug · ANDA
mycophenolic acid NDC 24979-161
Mycophenolate sodium 360 mg/1 · Tablet, Delayed release · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24979-161-44 | 24979016144 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (24979-161-44)Marketed from Nov 8, 2021 |
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)
- mycophenolic acid
- Generic name (nonproprietary)
- mycophenolic acid
- Active ingredients
- Mycophenolate sodium — 360 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214289
- Marketing start
- Marketing end
- Identifiers
- Product ID 24979-161_1dc7a361-08d4-47f5-a74c-6ad4bb35a976SPL ID 1dc7a361-08d4-47f5-a74c-6ad4bb35a976SPL set ID f7c05bf9-816f-41e6-999d-bb3c7abd2627RxCUI 485020, 485023UNII WX877SQI1GUPC 0324979161440, 0324979160443
- Pharmacologic class
- Antimetabolite Immunosuppressant
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
N424979016144followed by a unit qualifier and the quantityPackage 24979-0161-44. 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 .
Indications (excerpt from the label)
Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. ( 1.1 ) Use in combination with cyclosporine and corticosteroids. ( 1.1 ) Limitations of Use: Mycophenolic acid delayed release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. ( 1.2 ) 1.1 Prophylaxis of Organ Rejection in Kidney Transplant Mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney t…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214289
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 |
|---|---|---|---|---|
| mycophenolic acid | Mycophenolate sodium 360 mg/1 | Tablet, Delayed releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-246 |
| mycophenolic acid | Mycophenolate sodium 180 mg/1 | Tablet, Delayed releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-247 |
| mycophenolic acid | Mycophenolate sodium 180 mg/1 | Tablet, Delayed releaseOral | Upsher-Smith Laboratories, LLC | 24979-160 |