Prescription drug · ANDA
Mycophenolate Mofetil NDC 67877-225
Mycophenolate mofetil 500 mg/1 · Tablet, Film coated · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-225-01 | 6787702250167877022501 | 100 TABLET, FILM COATED in 1 BOTTLE (67877-225-01)Marketed from Nov 28, 2011 | |
| 67877-225-05 | 6787702250567877022505 | 500 TABLET, FILM COATED in 1 BOTTLE (67877-225-05)Marketed from Nov 28, 2011 | |
| 67877-225-38 | 6787702253867877022538 | 10 BLISTER PACK in 1 CARTON (67877-225-38) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 28, 2011 | |
| 67877-225-84 | 6787702258467877022584 | 3 BLISTER PACK in 1 CARTON (67877-225-84) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 28, 2011 |
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
- Ascend Laboratories, LLCNDC labeler code 67877
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091249
- Marketing start
- Listing expires
- Identifiers
- Product ID 67877-225_f8b5a092-55fd-4e91-aa56-98fe69f1c091SPL ID f8b5a092-55fd-4e91-aa56-98fe69f1c091SPL set ID 9f84ea84-2d8b-4d91-a33f-7dfb5df937dcRxCUI 199058, 200060UNII 9242ECW6R0UPC 0367877266053, 0367877266015, 0367877225050
- 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
N467877022501followed by a unit qualifier and the quantityPackage 67877-0225-01. 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)
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. Mycophenolate mofetil 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 67877-225
- What is NDC 67877-225?
- 67877-225 is the product NDC for Mycophenolate Mofetil, Mycophenolate mofetil 500 mg/1 tablet, film coated, listed with the FDA by Ascend Laboratories, LLC. It has 4 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?
- Ascend Laboratories, LLC, NDC labeler code 67877. 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 091249
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/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4275 |
| Mycophenolate Mofetil | Mycophenolate mofetil 500 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-558 |