What is NDC 63304-089?

63304-089 is the product NDC for Mesalamine, Mesalamine 500 mg/1 capsule, extended release, listed with the FDA by Sun Pharmaceutical Industries Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries Inc., NDC labeler code 63304. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Mesalamine?

58 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Mesalamine NDC 63304-089 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63304-089Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63304-0089Add 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
63304-089-13	63304008913	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-089-13)Marketed from May 13, 2022

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 — 500 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Sun Pharmaceutical Industries Inc.NDC labeler code 63304
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214585
Marketing start: May 13, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 63304-089_d41a599a-71be-4294-9b53-d1cbefe905d5SPL ID d41a599a-71be-4294-9b53-d1cbefe905d5SPL set ID c2f84490-70b8-4998-907d-a77e9f791de1RxCUI 476362UNII 4Q81I59GXCUPC 0363304089134
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

N463304008913 followed by a unit qualifier and the quantity

Package 63304-0089-13. 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, 2024.

Indications (excerpt from the label)

Mesalamine extended-release capsules are indicated for the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients. Mesalamine extended-release capsules are an aminosalicylate indicated for the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63304-089

What is NDC 63304-089?: 63304-089 is the product NDC for Mesalamine, Mesalamine 500 mg/1 capsule, extended release, listed with the FDA by Sun Pharmaceutical Industries Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Mesalamine.
What is the active ingredient?: Mesalamine.
Who is the labeler?: Sun Pharmaceutical Industries Inc., NDC labeler code 63304. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mesalamine?: 58 other product NDCs are listed under this name. See all Mesalamine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Mesalamine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Mesalamine	Mesalamine 250 mg/1	Capsule, Extended releaseOral	Sandoz Inc	0781-2791	00781-2791-64
Mesalamine	Mesalamine 500 mg/1	Capsule, Extended releaseOral	Sandoz Inc	0781-2793	00781-2793-72
Mesalamine	Mesalamine 1.2 g/1	Tablet, Delayed releaseOral	Nuvaila Limited	84612-175	84612-0175-13
Mesalamine	Mesalamine 4 g/60mL	SuspensionRectal	ANI Pharmaceuticals, Inc.	70954-301	70954-0301-20
Mesalamine	Mesalamine 4 g/60mL	SuspensionRectal	KLM Laboratories Private Limited	84725-002	84725-0002-03
Mesalamine	Mesalamine 375 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-489	31722-0489-12
Mesalamine	Mesalamine 1000 mg/1	SuppositoryRectal	Rising Pharma Holdings, Inc.	16571-246	16571-0246-0316571-0246-72
Mesalamine	Mesalamine 800 mg/1	Tablet, Delayed releaseOral	Amneal Pharmaceuticals LLC	65162-360	65162-0360-18
Mesalamine	Mesalamine 1.2 g/1	Tablet, Delayed releaseOral	NorthStar RxLLC	72603-304	72603-0304-01
Mesalamine	Mesalamine 800 mg/1	Tablet, Delayed releaseOral	AvKARE	42291-489	42291-0489-18

All 59 Mesalamine NDCs