NDC codes

FDA NDC Directory
Product NDC (as listed)67877-717Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67877-0717Add 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 NDC11-digit (billing)PackageCopy
67877-717-0567877071705500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (67877-717-05)Marketed from Jul 16, 2021
67877-717-1267877071712120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (67877-717-12)Marketed from Jul 16, 2021

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214242
Marketing start
Listing expires
Other FDA classes
Aminosalicylic Acids (Chemical structure)
Identifiers
Product ID 67877-717_2eece16c-6316-4dc0-bf4f-25a3f1c08ae5SPL ID 2eece16c-6316-4dc0-bf4f-25a3f1c08ae5SPL set ID 43f69db3-81ac-4da4-a61f-fbba6299d9c2RxCUI 825130UNII 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

N467877071705 followed by a unit qualifier and the quantity

Package 67877-0717-05. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 214242

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

FDA NDC Directory listings under ANDA 214242
ProductStrengthForm · routeLabelerProduct NDC
MesalamineMesalamine .375 g/1Capsule, Extended releaseOralAvPAK50268-577
MesalamineMesalamine .375 g/1Capsule, Extended releaseOralAmerican Health Packaging60687-650

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