Mycophenolic Acid NDC 16729-261

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-261Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0261Add 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
16729-261-29	16729026129	120 TABLET, DELAYED RELEASE in 1 BOTTLE (16729-261-29)Marketed from Sep 11, 2017

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): Mycophenolic Acid
Generic name (nonproprietary): mycophenolic acid
Active ingredients: Mycophenolate sodium — 180 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Accord Healthcare Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202555
Marketing start: Sep 11, 2017
Listing expires: Dec 31, 2026
Identifiers: Product ID 16729-261_0f1eadde-f71c-76cb-e063-6294a90af04cSPL ID 0f1eadde-f71c-76cb-e063-6294a90af04cSPL set ID dc24aa15-330c-4698-872f-159d7e582b4bRxCUI 485020, 485023UNII WX877SQI1G
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

N416729026129 followed by a unit qualifier and the quantity

Package 16729-0261-29. 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 Jan 17, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Mycophenolic acid is an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. ( 1.1 ) Use in combination with cyclosporine and corticosteroids. ( 1.1 ) Limitations of Use: Mycophenolic acid delayed-release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. ( 1.2 ) 1.1 Prophylaxis of Organ Rejection in Kidney Transplant Mycophenolic acid delayed release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. Mycophenolic a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202555

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

FDA NDC Directory listings under ANDA 202555
Product	Strength	Form · route	Labeler	Product NDC
Mycophenolic Acid	Mycophenolate sodium 360 mg/1	Tablet, Delayed releaseOral	Accord Healthcare Inc.	16729-189