Prescription drug · ANDA
Mycophenolate mofetil NDC 73190-009
Mycophenolate mofetil 250 mg/1 · Capsule · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73190-009-01 | 73190000901 | 100 CAPSULE in 1 BOTTLE (73190-009-01)Marketed from Apr 25, 2025 | |
| 73190-009-50 | 73190000950 | 500 CAPSULE in 1 BOTTLE (73190-009-50)Marketed from Apr 25, 2025 |
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 — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090055
- Marketing start
- Listing expires
- Identifiers
- Product ID 73190-009_339a10d4-599c-e16c-e063-6294a90aa2a2SPL ID 339a10d4-599c-e16c-e063-6294a90aa2a2SPL set ID 339a10c4-e442-de9e-e063-6294a90a6208RxCUI 199058, 200060UNII 9242ECW6R0UPC 0300000000001
- 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
N473190000901followed by a unit qualifier and the quantityPackage 73190-0009-01. 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)
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 090055
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 250 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3799 |
| Mycophenolate mofetil | Mycophenolate mofetil 250 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-726 |
| Mycophenolate mofetil | Mycophenolate mofetil 250 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-830 |
| Mycophenolate mofetil | Mycophenolate mofetil 250 mg/1 | CapsuleOral | Strides Pharma Inc. | 42543-988 |