Prescription drug · ANDA
Mycophenolate Mofetil NDC 71610-033
Mycophenolate mofetil 500 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-033-53 | 7161000335371610003353 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-53)Marketed from Jul 1, 2019 | |
| 71610-033-60 | 7161000336071610003360 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-60)Marketed from Jul 1, 2019 | |
| 71610-033-70 | 7161000337071610003370 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-70)Marketed from Jan 19, 2018 | |
| 71610-033-80 | 7161000338071610003380 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-80)Marketed from Jul 1, 2019 | |
| 71610-033-90 | 7161000339071610003390 | 240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-90)Marketed from Jul 1, 2019 | |
| 71610-033-92 | 7161000339271610003392 | 270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-92)Marketed from Jul 1, 2019 | |
| 71610-033-98 | 7161000339871610003398 | 540 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-98)Marketed from Jul 1, 2019 |
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/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065521
- Marketing start
- Listing expires
- Identifiers
- Product ID 71610-033_11d3eb0d-489b-06c5-e063-6294a90a9d3bSPL ID 11d3eb0d-489b-06c5-e063-6294a90a9d3bSPL set ID 721564bc-7c0b-4418-ab49-0af362e74eb7RxCUI 200060UNII 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
N471610003353followed by a unit qualifier and the quantityPackage 71610-0033-53. 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)
INDICATIONS AND USAGE Renal, Cardiac, and Hepatic Transplant Mycophenolate mofetil is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Mycophenolate mofetil should be used concomitantly with cyclosporine and corticosteroids.
Excerpt only. Read the full label for complete information.
About NDC 71610-033
- What is NDC 71610-033?
- 71610-033 is the product NDC for Mycophenolate Mofetil, Mycophenolate mofetil 500 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 7 package NDCs, 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?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 |