Prescription drug · ANDA
Mycophenolic Acid NDC 82293-013
Mycophenolate sodium 360 mg/1 · Tablet, Delayed release · Oral · Novugen Pharma (USA) LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82293-013-10 | 82293001310 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (82293-013-10)Marketed from Sep 1, 2024 |
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
- Labeler
- Novugen Pharma (USA) LLC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216637
- Marketing start
- Listing expires
- Identifiers
- Product ID 82293-013_1f0154d5-686f-170e-e063-6394a90a67e6SPL ID 1f0154d5-686f-170e-e063-6394a90a67e6SPL set ID cbc3e916-09e2-4e6e-9e5e-98375f5e6d41RxCUI 485020, 485023UNII WX877SQI1G
- 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
N482293001310followed by a unit qualifier and the quantityPackage 82293-0013-10. 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)
Mycophenolic acid is 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 transplant. Mycophenolic a…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216637
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 180 mg/1 | Tablet, Delayed releaseOral | Novugen Pharma (USA) LLC. | 82293-012 |