Prescription drug · ANDA
mycophenolic acid NDC 68254-5002
Mycophenolate sodium 360 mg/1 · Tablet, Delayed release · Oral · CONCORD BIOTECH LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68254-5002-1 | 68254500201 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (68254-5002-1)Marketed from Dec 13, 2019 | |
| 68254-5002-2 | 68254500202 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (68254-5002-2)Marketed from Dec 13, 2019 |
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)
- mycophenolic acid
- Generic name (nonproprietary)
- mycophenolic acid
- Active ingredients
- Mycophenolate sodium — 360 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- CONCORD BIOTECH LIMITED
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211173
- Marketing start
- Listing expires
- Identifiers
- Product ID 68254-5002_47ef003d-aa2a-4b8e-9ab4-bba4cde21f09SPL ID 47ef003d-aa2a-4b8e-9ab4-bba4cde21f09SPL set ID a374549e-8afd-48fe-ae3f-368984689a2aRxCUI 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
N468254500201followed by a unit qualifier and the quantityPackage 68254-5002-01. 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)
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 211173
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 | Advagen Pharma Limited | 72888-200 |
| mycophenolic acid | Mycophenolate sodium 180 mg/1 | Tablet, Delayed releaseOral | Advagen Pharma Limited | 72888-199 |
| mycophenolic acid | Mycophenolate sodium 180 mg/1 | Tablet, Delayed releaseOral | CONCORD BIOTECH LIMITED | 68254-5001 |
| mycophenolic acid | Mycophenolate sodium 180 mg/1 | Tablet, Delayed releaseOral | Stellon Biotech Inc. | 85972-161 |
| mycophenolic acid | Mycophenolate sodium 360 mg/1 | Tablet, Delayed releaseOral | Stellon Biotech Inc. | 85972-162 |