Mesalamine NDC 50268-577

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-577Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0577Add 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
50268-577-15	50268057715	50 BLISTER PACK in 1 BOX (50268-577-15) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-577-11)Marketed from Jan 16, 2023

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 — .375 g/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: AvPAK
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214242
Marketing start: Jan 16, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 50268-577_2b4a9376-8515-3d10-e063-6394a90a0aadSPL ID 2b4a9376-8515-3d10-e063-6394a90a0aadSPL set ID f2657911-6f06-71fb-e053-2a95a90ae6f7RxCUI 825130UNII 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 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

N450268057715 followed by a unit qualifier and the quantity

Package 50268-0577-15. 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 9, 2025.

Indications (excerpt from the label)

Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults. Mesalamine extended-release capsule is an aminosalicylate indicated for the maintenance of remission of ulcerative colitis in adults. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214242

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

FDA NDC Directory listings under ANDA 214242
Product	Strength	Form · route	Labeler	Product NDC
Mesalamine	Mesalamine .375 g/1	Capsule, Extended releaseOral	American Health Packaging	60687-650
Mesalamine	Mesalamine .375 g/1	Capsule, Extended releaseOral	Ascend Laboratories, LLC	67877-717