Prescription drug · NDA
CellCept (Mycophenolate mofetil) NDC 0004-0259
Mycophenolate mofetil 250 mg/1 · Capsule · Oral · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0004-0259-01 | 0000402590100004025901 | 1 BOTTLE, PLASTIC in 1 CARTON (0004-0259-01) / 100 CAPSULE in 1 BOTTLE, PLASTICMarketed from May 3, 1995 | |
| 0004-0259-43 | 0000402594300004025943 | 1 BOTTLE, PLASTIC in 1 CARTON (0004-0259-43) / 500 CAPSULE in 1 BOTTLE, PLASTICMarketed from May 3, 1995 |
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)
- CellCept
- Generic name (nonproprietary)
- mycophenolate mofetil
- Active ingredients
- Mycophenolate mofetil — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Genentech, Inc.NDC labeler code 0004
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050722
- Marketing start
- Listing expires
- Identifiers
- Product ID 0004-0259_1e79ff42-b246-420f-96af-a7b8cbf6e76eSPL ID 1e79ff42-b246-420f-96af-a7b8cbf6e76eSPL set ID 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40RxCUI 199058, 200060, 213394, 311880, 311881, 616435, 616444, 616447UNII UXH81S8ZVB, 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
N400004025901followed by a unit qualifier and the quantityPackage 00004-0259-01. 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)
CELLCEPT [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. CELLCEPT 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.
About NDC 0004-0259
- What is NDC 0004-0259?
- 0004-0259 is the product NDC for CellCept (mycophenolate mofetil), Mycophenolate mofetil 250 mg/1 capsule, listed with the FDA by Genentech, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CellCept (Mycophenolate Mofetil).
- What is the active ingredient?
- Mycophenolate mofetil.
- Who is the labeler?
- Genentech, Inc., NDC labeler code 0004. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CellCept?
- 3 other product NDCs are listed under this name. See all CellCept NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other CellCept products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| CellCeptmycophenolate mofetil | Mycophenolate mofetil 200 mg/mL | Powder, For suspensionOral | Genentech, Inc. | 0004-0261 | 00004-0261-29 |
| CellCeptmycophenolate mofetil hydrochloride | Mycophenolate mofetil hydrochloride 500 mg/20mL | Injection, Powder, Lyophilized, For solutionIntravenous | Genentech, Inc. | 0004-0298 | 00004-0298-09 |
| CellCeptmycophenolate mofetil | Mycophenolate mofetil 500 mg/1 | Tablet, Film coatedOral | Genentech, Inc. | 0004-0260 | 00004-0260-0100004-0260-43 |