Mesalamine NDC 84612-175

NDC codes

FDA NDC Directory

Product NDC (as listed)84612-175Labeler and product segments. Claims need a package NDC.

Product NDC at billing width84612-0175Add 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
84612-175-13	84612017513	120 TABLET, DELAYED RELEASE in 1 BOTTLE (84612-175-13)Marketed from Jul 1, 2026

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): Mesalamine
Generic name (nonproprietary): mesalamine
Active ingredients: Mesalamine — 1.2 g/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Nuvaila Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211858
Marketing start: Jul 1, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 84612-175_5352a04b-3756-6513-e063-6294a90a7c0bSPL ID 5352a04b-3756-6513-e063-6294a90a7c0bSPL set ID 875d573f-99a1-426a-8321-4d511690d503RxCUI 686429UNII 4Q81I59GXCUPC 0384612175135
Pharmacologic class: Aminosalicylate

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

N484612017513 followed by a unit qualifier and the quantity

Package 84612-0175-13. 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 Jun 3, 2026.

Indications (excerpt from the label)

Mesalamine delayed-release tablets are indicated for the: induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. Mesalamine delayed-release tablets are an aminosalicylate indicated for the: induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. ( 1 ) treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211858

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

FDA NDC Directory listings under ANDA 211858
Product	Strength	Form · route	Labeler	Product NDC
Mesalamine	Mesalamine 1.2 g/1	Tablet, Delayed releaseOral	Sun Pharmaceutical Industries, Inc.	63304-175