Prescription drug · ANDA
Mycophenolate Mofetil NDC 31722-878
Mycophenolate mofetil 250 mg/1 · Capsule · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-878-01 | 31722087801 | 1 BOTTLE in 1 CARTON (31722-878-01) / 100 CAPSULE in 1 BOTTLEMarketed from Oct 22, 2024 | |
| 31722-878-05 | 31722087805 | 500 CAPSULE in 1 BOTTLE (31722-878-05)Marketed from Dec 12, 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 — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207022
- Marketing start
- Listing expires
- Identifiers
- Product ID 31722-878_3b604c8c-672d-7b1e-e063-6394a90a255fSPL ID 3b604c8c-672d-7b1e-e063-6394a90a255fSPL set ID 118e9bc8-c1a9-41d0-89e6-251f3be0b99cRxCUI 199058UNII 9242ECW6R0UPC 0331722878012
- 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
N431722087801followed by a unit qualifier and the quantityPackage 31722-0878-01. 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 capsules 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 capsules are 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.