Prescription drug · ANDA
mycophenolate mofetil NDC 83270-000
Mycophenolate mofetil 500 mg/20mL · Injection, Powder, Lyophilized, For solution · Intravenous · ONESOURCE SPECIALTY PHARMA LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83270-000-04 | 8327000000483270000004 | 4 VIAL in 1 CARTON (83270-000-04) / 20 mL in 1 VIALMarketed from Apr 30, 2023 |
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 — 500 mg/20mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- ONESOURCE SPECIALTY PHARMA LIMITEDNDC labeler code 83270
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216390
- Marketing start
- Listing expires
- Identifiers
- Product ID 83270-000_42ed2be4-bc3d-281a-e063-6394a90aeb7fSPL ID 42ed2be4-bc3d-281a-e063-6394a90aeb7fSPL set ID 461a252f-ff81-4e08-b256-a497b14835faRxCUI 311881UNII 9242ECW6R0UPC 0383270000018
- 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
N483270000004followed by a unit qualifier and the quantityPackage 83270-0000-04. 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 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 recipients of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. (1)
Excerpt only. Read the full label for complete information.
About NDC 83270-000
- What is NDC 83270-000?
- 83270-000 is the product NDC for mycophenolate mofetil, Mycophenolate mofetil 500 mg/20mL injection, powder, lyophilized, for solution, listed with the FDA by ONESOURCE SPECIALTY PHARMA LIMITED. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- mycophenolate mofetil.
- What is the active ingredient?
- Mycophenolate mofetil.
- Who is the labeler?
- ONESOURCE SPECIALTY PHARMA LIMITED, NDC labeler code 83270. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for mycophenolate mofetil?
- 57 other product NDCs are listed under this name. See all mycophenolate mofetil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other mycophenolate mofetil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| mycophenolate mofetil | Mycophenolate mofetil 250 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0161 | 55154-0161-00 |
| Mycophenolate Mofetil | Mycophenolate mofetil 200 mg/mL | Powder, For suspensionOral | Strides Pharma Science Limited | 64380-899 | 64380-0899-00 |
| Mycophenolate Mofetil | Mycophenolate mofetil 200 mg/mL | Powder, For suspensionOral | QUAGEN PHARMACEUTICALS LLC | 70752-294 | 70752-0294-60 |
| Mycophenolate Mofetil | Mycophenolate mofetil 200 mg/mL | Powder, For suspensionOral | NorthStar Rx LLC | 72603-751 | 72603-0751-01 |
| mycophenolate mofetil | Mycophenolate mofetil 250 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7466 | 00904-7466-61 |
| Mycophenolate Mofetil | Mycophenolate mofetil 250 mg/1 | CapsuleOral | Wuxi Fortune Pharmaceutical Co.,Ltd. | 65050-2073 | 65050-2073-00 |
| Mycophenolate mofetil | Mycophenolate mofetil 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4377 | 70518-4377-00 |
| Mycophenolate mofetil | Mycophenolate mofetil 250 mg/1 | CapsuleOral | AvKARE | 73190-009 | 73190-0009-0173190-0009-50 |
| Mycophenolate mofetil | Mycophenolate mofetil 500 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-010 | 73190-0010-0173190-0010-50 |
| mycophenolate mofetil | Mycophenolate mofetil 250 mg/1 | CapsuleOral | American Health Packaging | 60687-885 | 60687-0885-01 |
Other NDCs under ANDA 216390
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 |
|---|---|---|---|---|
| mycophenolate mofetil | Mycophenolate mofetil 500 mg/20mL | Injection, Powder, Lyophilized, For solutionIntravenous | ARMAS PHARMACEUTICALS INC | 72485-415 |