Prescription drug · ANDA
Mycophenolate mofetil NDC 82804-033
Mycophenolate mofetil 500 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-033-30 | 82804003330 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-30)Marketed from Oct 25, 2023 | |
| 82804-033-60 | 82804003360 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-60)Marketed from Oct 25, 2023 | |
| 82804-033-90 | 82804003390 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-90)Marketed from Oct 25, 2023 |
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)
- Mycophenolate mofetil
- Generic name (nonproprietary)
- mycophenolate mofetil
- Active ingredients
- Mycophenolate mofetil — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090456
- Marketing start
- Listing expires
- Identifiers
- Product ID 82804-033_ce06afcb-4e6c-4b78-8bad-9909c8fffa52SPL ID ce06afcb-4e6c-4b78-8bad-9909c8fffa52SPL set ID ce06afcb-4e6c-4b78-8bad-9909c8fffa52RxCUI 200060UNII 9242ECW6R0UPC 0382804033300
- 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
N482804003330followed by a unit qualifier and the quantityPackage 82804-0033-30. 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)
Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)] , heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)] , in combination with other immunosuppressants. Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090456
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 |
|---|---|---|---|---|
| Mycophenolate mofetil | Mycophenolate mofetil 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2767 |
| Mycophenolate mofetil | Mycophenolate mofetil 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-438 |
| Mycophenolate mofetil | Mycophenolate mofetil 500 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3571 |
| Mycophenolate mofetil | Mycophenolate mofetil 500 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-725 |
| Mycophenolate mofetil | Mycophenolate mofetil 500 mg/1 | Tablet, Film coatedOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-836 |
| Mycophenolate mofetil | Mycophenolate mofetil 500 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-010 |
| Mycophenolate mofetil | Mycophenolate mofetil 500 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7078 |
| Mycophenolate mofetil | Mycophenolate mofetil 500 mg/1 | Tablet, Film coatedOral | Strides Pharma Inc. | 42543-989 |
| Mycophenolate mofetil | Mycophenolate mofetil 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3767 |
| Mycophenolate mofetil | Mycophenolate mofetil 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4377 |