Prescription drug · ANDA
Mycophenolic Acid NDC 0904-6785
Mycophenolate sodium 180 mg/1 · Tablet, Delayed release · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6785-04 | 00904678504 | 30 BLISTER PACK in 1 CARTON (0904-6785-04) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Aug 21, 2012 | |
| 0904-6785-61 | 00904678561 | 100 BLISTER PACK in 1 CARTON (0904-6785-61) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Aug 21, 2012 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 180 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091558
- Marketing start
- Listing expires
- Identifiers
- Product ID 0904-6785_340248b0-f124-447c-9f42-99a9c9625a34SPL ID 340248b0-f124-447c-9f42-99a9c9625a34SPL set ID 93763b39-ba21-449b-bdc5-254ba57154e4RxCUI 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
N400904678504followed by a unit qualifier and the quantityPackage 00904-6785-04. 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 ki…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091558
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 | Major Pharmaceuticals | 0904-6786 |
| Mycophenolic Acid | Mycophenolate sodium 180 mg/1 | Tablet, Delayed releaseOral | Apotex Corp | 60505-2965 |
| Mycophenolic Acid | Mycophenolate sodium 360 mg/1 | Tablet, Delayed releaseOral | Apotex Corp | 60505-2966 |
| Mycophenolic Acid | Mycophenolate sodium 180 mg/1 | Tablet, Delayed releaseOral | Golden State Medical Supply, Inc. | 60429-016 |
| Mycophenolic Acid | Mycophenolate sodium 360 mg/1 | Tablet, Delayed releaseOral | Golden State Medical Supply, Inc. | 60429-017 |
| Mycophenolic Acid | Mycophenolate sodium 180 mg/1 | Tablet, Delayed releaseOral | American Health Packaging | 68084-907 |
| Mycophenolic Acid | Mycophenolate sodium 360 mg/1 | Tablet, Delayed releaseOral | American Health Packaging | 68084-918 |