mycophenolate mofetil NDC 50268-557

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-557Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0557Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
50268-557-15	50268055715	50 BLISTER PACK in 1 BOX (50268-557-15) / 1 CAPSULE in 1 BLISTER PACK (50268-557-11)Marketed from May 15, 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 — 250 mg/1
Dosage form: Capsule
Route: Oral
Labeler: AvPAK
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200197
Marketing start: May 15, 2023
Listing expires: Dec 31, 2027
Identifiers: Product ID 50268-557_59e3c938-86a9-3d53-e063-6394a90a72d3SPL ID 59e3c938-86a9-3d53-e063-6394a90a72d3SPL set ID fbbe6521-0e21-5372-e053-6394a90ae5e4RxCUI 199058, 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

N450268055715 followed by a unit qualifier and the quantity

Package 50268-0557-15. 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 Aug 25, 2026. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200197

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 200197
Product	Strength	Form · route	Labeler	Product NDC
mycophenolate mofetil	Mycophenolate mofetil 250 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-266
mycophenolate mofetil	Mycophenolate mofetil 250 mg/1	CapsuleOral	American Health Packaging	60687-885
mycophenolate mofetil	Mycophenolate mofetil 250 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-0161
mycophenolate mofetil	Mycophenolate mofetil 250 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7466