Prescription drug · NDA
Myfortic (Mycophenolic acid) NDC 0078-0385
Mycophenolate sodium 180 mg/1 · Tablet, Delayed release · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0385-66 | 0007803856600078038566 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0385-66)Marketed from Feb 27, 2004 |
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)
- Myfortic
- Generic name (nonproprietary)
- mycophenolic acid
- Active ingredients
- Mycophenolate sodium — 180 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050791
- Marketing start
- Listing expires
- Identifiers
- Product ID 0078-0385_dd888996-35e0-4e02-af87-7557820412bcSPL ID dd888996-35e0-4e02-af87-7557820412bcSPL set ID eed26501-890d-4ff6-88e7-6dbea4726e53RxCUI 485020, 485023, 616449, 616450UNII WX877SQI1GUPC 0300780386661
- 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
N400078038566followed by a unit qualifier and the quantityPackage 00078-0385-66. 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)
Myfortic is an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. ( 1.1 ) Use in combination with cyclosporine and corticosteroids. ( 1.1 ) Limitations of Use : Myfortic delayed-release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. ( 1.2 ) 1.1 Prophylaxis of Organ Rejection in Kidney Transplant Myfortic ® (mycophenolic acid) is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. Myfortic is indicated for the prophylaxis o…
Excerpt only. Read the full label for complete information.
About NDC 0078-0385
- What is NDC 0078-0385?
- 0078-0385 is the product NDC for Myfortic (mycophenolic acid), Mycophenolate sodium 180 mg/1 tablet, delayed release, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Myfortic (Mycophenolic acid).
- What is the active ingredient?
- Mycophenolate sodium.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Myfortic?
- 1 other product NDC are listed under this name. See all Myfortic NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Myfortic products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Myforticmycophenolic acid | Mycophenolate sodium 360 mg/1 | Tablet, Delayed releaseOral | Novartis Pharmaceuticals Corporation | 0078-0386 | 00078-0386-66 |
Other NDCs under NDA 050791
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Myforticmycophenolic acid | Mycophenolate sodium 360 mg/1 | Tablet, Delayed releaseOral | Novartis Pharmaceuticals Corporation | 0078-0386 |