Prescription drug · ANDA
Mycophenolate Mofetil NDC 0527-5160
Mycophenolate mofetil 200 mg/mL · Powder, For suspension · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-5160-82 | 00527516082 | 1 BOTTLE, PLASTIC in 1 CARTON (0527-5160-82) / 225 mL in 1 BOTTLE, PLASTICMarketed from Jul 29, 2021 |
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)
- Mycophenolate Mofetil
- Generic name (nonproprietary)
- mycophenolate mofetil
- Active ingredients
- Mycophenolate mofetil — 200 mg/mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Lannett Company, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214525
- Marketing start
- Listing expires
- Identifiers
- Product ID 0527-5160_6cb7ed46-e457-4e92-8a15-e771e3dca2d5SPL ID 6cb7ed46-e457-4e92-8a15-e771e3dca2d5SPL set ID 24c0b94a-c141-44b6-a6f0-ade1669b254cRxCUI 311880UNII 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
N400527516082followed by a unit qualifier and the quantityPackage 00527-5160-82. 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 214525
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 200 mg/mL | Powder, For suspensionOral | QUAGEN PHARMACEUTICALS LLC | 70752-294 |