What is NDC 65649-103?

65649-103 is the product NDC for Apriso (mesalamine), Mesalamine 375 mg/1 capsule, extended release, listed with the FDA by Salix Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Salix Pharmaceuticals, Inc., NDC labeler code 65649. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Apriso?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Apriso NDC 65649-103 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65649-103Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65649-0103Add 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
65649-103-01	6564901030165649010301	1 BOTTLE in 1 CARTON (65649-103-01) / 4 CAPSULE, EXTENDED RELEASE in 1 BOTTLEMarketed from Oct 31, 2008 · Sample package
65649-103-02	6564901030265649010302	1 BOTTLE in 1 CARTON (65649-103-02) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLEMarketed from Oct 31, 2008

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): Apriso
Generic name (nonproprietary): mesalamine
Active ingredients: Mesalamine — 375 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Salix Pharmaceuticals, Inc.NDC labeler code 65649
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022301
Marketing start: Oct 31, 2008
Listing expires: Dec 31, 2027
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 65649-103_5a0ee848-80a0-294e-e063-6394a90a08aaSPL ID 5a0ee848-80a0-294e-e063-6394a90a08aaSPL set ID 7951139c-b271-45a4-b523-34b23800917bRxCUI 825130, 825134UNII 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

N465649010301 followed by a unit qualifier and the quantity

Package 65649-0103-01. 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 Aug 27, 2026.

Indications (excerpt from the label)

APRISO ® is indicated for the maintenance of remission of ulcerative colitis in adults. APRISO 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)

About NDC 65649-103

What is NDC 65649-103?: 65649-103 is the product NDC for Apriso (mesalamine), Mesalamine 375 mg/1 capsule, extended release, listed with the FDA by Salix Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Apriso (Mesalamine).
What is the active ingredient?: Mesalamine.
Who is the labeler?: Salix Pharmaceuticals, Inc., NDC labeler code 65649. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Apriso?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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
mesalamine	Mesalamine 375 mg/1	Capsule, Extended releaseOral	Teva Pharmaceuticals USA, Inc.	0093-9224

Apriso (Mesalamine) NDC 65649-103