Mesalamine NDC 0472-1915

NDC codes

FDA NDC Directory

Product NDC (as listed)0472-1915Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00472-1915Add 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
0472-1915-30	00472191530	30 POUCH in 1 BOX (0472-1915-30) / 1 SUPPOSITORY in 1 POUCH (0472-1915-01)Marketed from Apr 23, 2021

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 1000 mg/1
Dosage form: Suppository
Route: Rectal
Labeler: Actavis Pharma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205654
Marketing start: Apr 23, 2021
Marketing end: Nov 30, 2026
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 0472-1915_380df1f0-2282-4c49-bd7c-40b244f875d4SPL ID 380df1f0-2282-4c49-bd7c-40b244f875d4SPL set ID 73317da3-cba0-4106-9e88-79b0e2f642afRxCUI 248420UNII 4Q81I59GXC
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N400472191530 followed by a unit qualifier and the quantity

Package 00472-1915-30. 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 24, 2026.

Indications (excerpt from the label)

Mesalamine suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. Mesalamine suppositories are an aminosalicylate indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)