Mesalamine NDC 46708-724

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-724Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0724Add 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
46708-724-35	46708072435	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-724-35)Marketed from Nov 3, 2022
46708-724-91	46708072491	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-724-91)Marketed from Nov 3, 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 — .375 g/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216967
Marketing start: Nov 3, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 46708-724_4ef59b85-e5a5-479f-a1fe-e1cee4d87670SPL ID 4ef59b85-e5a5-479f-a1fe-e1cee4d87670SPL set ID 4ef59b85-e5a5-479f-a1fe-e1cee4d87670RxCUI 825130UNII 4Q81I59GXCUPC 0346708724351
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

N446708072435 followed by a unit qualifier and the quantity

Package 46708-0724-35. 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

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