What is NDC 63304-175?

63304-175 is the product NDC for Mesalamine, Mesalamine 1.2 g/1 tablet, delayed 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 63304-175 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63304-175Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63304-0175Add 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
63304-175-13	6330401751363304017513	120 TABLET, DELAYED RELEASE in 1 BOTTLE (63304-175-13)Marketed from Feb 1, 2019

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: Sun Pharmaceutical Industries, Inc.NDC labeler code 63304
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211858
Marketing start: Feb 1, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 63304-175_3f29d761-eab5-4f6b-a4f4-ffcc072648e3SPL ID 3f29d761-eab5-4f6b-a4f4-ffcc072648e3SPL set ID fd8b02de-7dfa-444d-a1f8-1436b578e0cbRxCUI 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

N463304017513 followed by a unit qualifier and the quantity

Package 63304-0175-13. 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 Dec 1, 2023.

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)

About NDC 63304-175

What is NDC 63304-175?: 63304-175 is the product NDC for Mesalamine, Mesalamine 1.2 g/1 tablet, delayed 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 4 g/60mL	SuspensionRectal	KLM Laboratories Private Limited	84725-002	84725-0002-0484725-0002-10
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 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

Other NDCs under ANDA 211858

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

FDA NDC Directory listings under ANDA 211858
Product	Strength	Form · route	Labeler	Product NDC
Mesalamine	Mesalamine 1.2 g/1	Tablet, Delayed releaseOral	Nuvaila Limited	84612-175