mesalamine NDC 68682-113

NDC codes

FDA NDC Directory

Product NDC (as listed)68682-113Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68682-0113Add 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
68682-113-20	68682011320	1 BOTTLE in 1 CARTON (68682-113-20) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLEMarketed from Jul 19, 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 — 375 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Oceanside Pharmaceuticals
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 022301
Marketing start: Jul 19, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 68682-113_0ce2b1db-0b45-4548-e063-6294a90a84f1SPL ID 0ce2b1db-0b45-4548-e063-6294a90a84f1SPL set ID cfe4800f-868f-46fd-8b9a-977a91ae5fbeRxCUI 825130UNII 4Q81I59GXCUPC 0368682113204
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

N468682011320 followed by a unit qualifier and the quantity

Package 68682-0113-20. 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 Oct 31, 2023.

Indications (excerpt from the label)

Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults. Mesalamine 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 NDA 022301

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

FDA NDC Directory listings under NDA 022301
Product	Strength	Form · route	Labeler	Product NDC
Aprisomesalamine	Mesalamine 375 mg/1	Capsule, Extended releaseOral	Salix Pharmaceuticals, Inc.	65649-103
mesalamine	Mesalamine 375 mg/1	Capsule, Extended releaseOral	Teva Pharmaceuticals USA, Inc.	0093-9224