Mesalamine NDC 60687-397

NDC codes

FDA NDC Directory

Product NDC (as listed)60687-397Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60687-0397Add 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
60687-397-25	60687039725	30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-397-25) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-397-95)Marketed from Oct 11, 2018

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: American Health Packaging
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091640
Marketing start: Oct 11, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 60687-397_278689c8-9371-59ed-e063-6294a90a7bdaSPL ID 278689c8-9371-59ed-e063-6294a90a7bdaSPL set ID 77140634-9f32-40ca-8c83-9fcc3e373c16RxCUI 686429UNII 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

N460687039725 followed by a unit qualifier and the quantity

Package 60687-0397-25. 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 22, 2024.

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 091640

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

FDA NDC Directory listings under ANDA 091640
Product	Strength	Form · route	Labeler	Product NDC
mesalamine	Mesalamine 1.2 g/1	Tablet, Delayed releaseOral	Major Pharmaceuticals	0904-6832
mesalamine	Mesalamine 1.2 g/1	Tablet, Delayed releaseOral	Zydus Lifesciences Limited	70771-1071
mesalamine	Mesalamine 1.2 g/1	Tablet, Delayed releaseOral	Zydus Pharmaceuticals USA Inc.	68382-711
mesalamine	Mesalamine 1.2 g/1	Tablet, Delayed releaseOral	Golden State Medical Supply, Inc.	51407-900