Prescription drug · ANDA
mycophenolate mofetil NDC 60687-885
Mycophenolate mofetil 250 mg/1 · Capsule · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-885-01 | 60687088501 | 100 BLISTER PACK in 1 CARTON (60687-885-01) / 1 CAPSULE in 1 BLISTER PACK (60687-885-11)Marketed from Mar 2, 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
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200197
- Marketing start
- Listing expires
- Identifiers
- Product ID 60687-885_2f8663a1-6d47-1d0e-e063-6394a90ac57fSPL ID 2f8663a1-6d47-1d0e-e063-6394a90ac57fSPL set ID 75a76397-bb62-4014-8488-949a711b25f0RxCUI 199058UNII 9242ECW6R0
- 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
N460687088501followed by a unit qualifier and the quantityPackage 60687-0885-01. 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 200197
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 | Ascend Laboratories, LLC | 67877-266 |
| mycophenolate mofetil | Mycophenolate mofetil 250 mg/1 | CapsuleOral | AvPAK | 50268-557 |
| mycophenolate mofetil | Mycophenolate mofetil 250 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0161 |
| mycophenolate mofetil | Mycophenolate mofetil 250 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7466 |