Prescription drug · NDA
CellCept (Mycophenolate mofetil hydrochloride) NDC 0004-0298
Mycophenolate mofetil hydrochloride 500 mg/20mL · Injection, Powder, Lyophilized, For solution · Intravenous · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0004-0298-09 | 0000402980900004029809 | 4 VIAL in 1 CARTON (0004-0298-09) / 20 mL in 1 VIALMarketed from Aug 12, 1998 |
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 hydrochloride
- Active ingredients
- Mycophenolate mofetil hydrochloride — 500 mg/20mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Genentech, Inc.NDC labeler code 0004
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050758
- Marketing start
- Listing expires
- Identifiers
- Product ID 0004-0298_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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400004029809followed by a unit qualifier and the quantityPackage 00004-0298-09. 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 0004-0298
- What is NDC 0004-0298?
- 0004-0298 is the product NDC for CellCept (mycophenolate mofetil hydrochloride), Mycophenolate mofetil hydrochloride 500 mg/20mL injection, powder, lyophilized, for solution, listed with the FDA by Genentech, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CellCept (Mycophenolate Mofetil hydrochloride).
- What is the active ingredient?
- Mycophenolate mofetil hydrochloride.
- 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 | Mycophenolate mofetil 500 mg/1 | Tablet, Film coatedOral | Genentech, Inc. | 0004-0260 | 00004-0260-0100004-0260-43 |
| CellCeptmycophenolate mofetil | Mycophenolate mofetil 250 mg/1 | CapsuleOral | Genentech, Inc. | 0004-0259 | 00004-0259-0100004-0259-43 |