Prescription drug · ANDA
Mycophenolate Mofetil NDC 0781-2067
Mycophenolate mofetil 250 mg/1 · Capsule · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-2067-01 | 00781206701 | 100 CAPSULE in 1 BOTTLE (0781-2067-01)Marketed from Oct 15, 2008 | |
| 0781-2067-05 | 00781206705 | 500 CAPSULE in 1 BOTTLE (0781-2067-05)Marketed from Oct 15, 2008 | |
| 0781-2067-72 | 00781206772 | 120 CAPSULE in 1 BOTTLE (0781-2067-72)Marketed from Oct 15, 2008 | |
| 0781-2067-89 | 00781206789 | 12 CAPSULE in 1 CARTON (0781-2067-89)Marketed from Oct 15, 2008 |
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 — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065379
- Marketing start
- Listing expires
- Identifiers
- Product ID 0781-2067_8d255117-cfa8-4893-8e2e-945eee7b12c4SPL ID 8d255117-cfa8-4893-8e2e-945eee7b12c4SPL set ID 99b2eb58-8d14-48fc-bbe1-aacb711a783eRxCUI 199058, 200060UNII 9242ECW6R0UPC 0307812067017
- 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
N400781206701followed by a unit qualifier and the quantityPackage 00781-2067-01. 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.