What is NDC 16571-246?

16571-246 is the product NDC for Mesalamine, Mesalamine 1000 mg/1 suppository, listed with the FDA by Rising Pharma Holdings, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Rising Pharma Holdings, Inc., NDC labeler code 16571. 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 16571-246 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-246Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0246Add 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
16571-246-03	1657102460316571024603	5 BLISTER PACK in 1 CARTON (16571-246-03) / 6 SUPPOSITORY in 1 BLISTER PACK (16571-246-16)Marketed from Apr 14, 2025
16571-246-72	1657102467216571024672	12 BLISTER PACK in 1 CARTON (16571-246-72) / 6 SUPPOSITORY in 1 BLISTER PACK (16571-246-16)Marketed from Apr 14, 2025

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 — 1000 mg/1
Dosage form: Suppository
Route: Rectal
Labeler: Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219028
Marketing start: Apr 14, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 16571-246_92e26463-9c71-456e-b800-351162846b68SPL ID 92e26463-9c71-456e-b800-351162846b68SPL set ID c26ae6cb-041b-4cfc-90ca-c4e1cb23458cRxCUI 248420UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N416571024603 followed by a unit qualifier and the quantity

Package 16571-0246-03. 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 10, 2025.

Indications (excerpt from the label)

Mesalamine suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. Mesalamine suppositories are an aminosalicylate indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16571-246

What is NDC 16571-246?: 16571-246 is the product NDC for Mesalamine, Mesalamine 1000 mg/1 suppository, listed with the FDA by Rising Pharma Holdings, Inc.. It has 2 package NDCs, 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?: Rising Pharma Holdings, Inc., NDC labeler code 16571. 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 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
Mesalamine	Mesalamine .375 g/1	Capsule, Extended releaseOral	Ingenus Pharmaceuticals, LLC	50742-371	50742-0371-12

All 59 Mesalamine NDCs