Mycophenolate Mofetil NDC 71610-033

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-033Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0033Add 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
71610-033-53	71610003353	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-53)Marketed from Jul 1, 2019
71610-033-60	71610003360	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-60)Marketed from Jul 1, 2019
71610-033-70	71610003370	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-70)Marketed from Jan 19, 2018
71610-033-80	71610003380	180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-80)Marketed from Jul 1, 2019
71610-033-90	71610003390	240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-90)Marketed from Jul 1, 2019
71610-033-92	71610003392	270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-92)Marketed from Jul 1, 2019
71610-033-98	71610003398	540 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-98)Marketed from Jul 1, 2019

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: Aphena Pharma Solutions - Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065521
Marketing start: Jan 6, 2015
Listing expires: Dec 31, 2026
Identifiers: Product ID 71610-033_11d3eb0d-489b-06c5-e063-6294a90a9d3bSPL ID 11d3eb0d-489b-06c5-e063-6294a90a9d3bSPL set ID 721564bc-7c0b-4418-ab49-0af362e74eb7RxCUI 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

N471610003353 followed by a unit qualifier and the quantity

Package 71610-0033-53. 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 Feb 20, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Renal, Cardiac, and Hepatic Transplant Mycophenolate mofetil is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Mycophenolate mofetil should be used concomitantly with cyclosporine and corticosteroids.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)