Mesalamine NDC 62135-714

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-714Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0714Add 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
62135-714-12	62135071412	120 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-714-12)Marketed from Jul 21, 2023
62135-714-60	62135071460	60 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-714-60)Marketed from Jul 21, 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 — 1.2 g/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Chartwell RX, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217337
Marketing start: Jun 3, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 62135-714_462a53ff-353f-3cdf-e063-6394a90af853SPL ID 462a53ff-353f-3cdf-e063-6394a90af853SPL set ID 9703f92d-1d15-4376-8b2b-51502c266012RxCUI 686429UNII 4Q81I59GXCUPC 0362135714123, 0362135714604
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

N462135071412 followed by a unit qualifier and the quantity

Package 62135-0714-12. 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 Dec 17, 2025.

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. Pediatric use information is approved for Takeda Pharmaceuticals U.S.A., Inc.’s LIALDA (mesalamine) delayed-release tablets. However, due to Takeda Pharmaceuticals U.S.A., Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. 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 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 217337

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

FDA NDC Directory listings under ANDA 217337
Product	Strength	Form · route	Labeler	Product NDC
Mesalamine	Mesalamine 1.2 g/1	Tablet, Delayed releaseOral	Lannett Company Inc.	0527-3012
Mesalamine	Mesalamine 1.2 g/1	Tablet, Delayed releaseOral	Bryant Ranch Prepack	72162-2213