Prescription drug · ANDA
Mycophenolate mofetil NDC 42543-988
Mycophenolate mofetil 250 mg/1 · Capsule · Oral · Strides Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42543-988-07 | 4254309880742543098807 | 500 CAPSULE in 1 BOTTLE, PLASTIC (42543-988-07)Marketed from Feb 28, 2025 |
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 — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Strides Pharma Inc.NDC labeler code 42543
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090055
- Marketing start
- Listing expires
- Identifiers
- Product ID 42543-988_f2e4fa33-6e09-487c-aa77-bb4937983db6SPL ID f2e4fa33-6e09-487c-aa77-bb4937983db6SPL set ID 9d8c09fc-1df2-4f39-8e1a-c4b296d1a260RxCUI 199058, 200060UNII 9242ECW6R0UPC 0342543988064, 0342543989061
- 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
N442543098807followed by a unit qualifier and the quantityPackage 42543-0988-07. 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 42543-988
- What is NDC 42543-988?
- 42543-988 is the product NDC for Mycophenolate mofetil, Mycophenolate mofetil 250 mg/1 capsule, listed with the FDA by Strides Pharma Inc.. 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?
- Strides Pharma Inc., NDC labeler code 42543. 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 090055
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 250 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-830 |
| Mycophenolate mofetil | Mycophenolate mofetil 250 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-726 |
| Mycophenolate mofetil | Mycophenolate mofetil 250 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3799 |
| Mycophenolate mofetil | Mycophenolate mofetil 250 mg/1 | CapsuleOral | AvKARE | 73190-009 |