Mycophenolate Mofetil NDC 68254-5000

NDC codes

FDA NDC Directory

Product NDC (as listed)68254-5000Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68254-5000Add 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
68254-5000-1	68254500001	100 CAPSULE in 1 BOTTLE (68254-5000-1)Marketed from Oct 1, 2019
68254-5000-2	68254500002	500 CAPSULE in 1 BOTTLE (68254-5000-2)Marketed from Oct 1, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: CONCORD BIOTECH LIMITED
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210181
Marketing start: Oct 1, 2019
Listing expires: Dec 31, 2026
Identifiers: Product ID 68254-5000_6eb2ddd0-ab23-44ae-a1ce-acc44e4f7e29SPL ID 6eb2ddd0-ab23-44ae-a1ce-acc44e4f7e29SPL set ID 64ac00ee-298c-49cf-a91c-78019a0d014dRxCUI 199058, 200060UNII 9242ECW6R0UPC 0368254500333
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

N468254500001 followed by a unit qualifier and the quantity

Package 68254-5000-01. 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 Jul 25, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

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 ) 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210181

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

FDA NDC Directory listings under ANDA 210181
Product	Strength	Form · route	Labeler	Product NDC
Mycophenolate Mofetil	Mycophenolate mofetil 250 mg/1	CapsuleOral	Advagen Pharma Limited	72888-192
Mycophenolate Mofetil	Mycophenolate mofetil 250 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4036