Mesalamine NDC 60687-408

NDC codes

FDA NDC Directory

Product NDC (as listed)60687-408Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60687-0408Add 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
60687-408-25	60687040825	30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-408-25) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-408-95)Marketed from Apr 17, 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): Mesalamine
Generic name (nonproprietary): mesalamine
Active ingredients: Mesalamine — 800 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: American Health Packaging
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203286
Marketing start: Apr 17, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 60687-408_276fafe8-8a19-bee4-e063-6394a90a80a9SPL ID 276fafe8-8a19-bee4-e063-6394a90a80a9SPL set ID a74ab9f4-ffcd-4bbf-88a5-342e6a38aabbRxCUI 833234UNII 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

N460687040825 followed by a unit qualifier and the quantity

Package 60687-0408-25. 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 Nov 21, 2024.

Indications (excerpt from the label)

Mesalamine delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults. Limitations of Use: Safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established. Mesalamine delayed-release tablets are aminosalicylate indicated for the treatment of moderately active ulcerative colitis in adults. (1) Limitation of Use: Safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203286

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

FDA NDC Directory listings under ANDA 203286
Product	Strength	Form · route	Labeler	Product NDC
mesalamine	Mesalamine 800 mg/1	Tablet, Delayed releaseOral	Zydus Pharmaceuticals USA Inc.	68382-435
mesalamine	Mesalamine 800 mg/1	Tablet, Delayed releaseOral	Zydus Lifesciences Limited	70771-1110