Prescription drug · ANDA
Mycophenolate Mofetil NDC 59651-638
Mycophenolate mofetil 500 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-638-01 | 59651063801 | 100 TABLET, FILM COATED in 1 BOTTLE (59651-638-01)Marketed from Feb 20, 2024 | |
| 59651-638-05 | 59651063805 | 500 TABLET, FILM COATED in 1 BOTTLE (59651-638-05)Marketed from Feb 20, 2024 |
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
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217937
- Marketing start
- Listing expires
- Identifiers
- Product ID 59651-638_abdd39b5-dac9-4e5c-9722-17473947909dSPL ID abdd39b5-dac9-4e5c-9722-17473947909dSPL set ID 8faf357b-99a1-440b-8eac-8545cb19a69cRxCUI 200060UNII 9242ECW6R0UPC 0359651638019
- 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
N459651063801followed by a unit qualifier and the quantityPackage 59651-0638-01. 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 tablets are 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.