NDC codes

FDA NDC Directory
Product NDC (as listed)84725-002Labeler and product segments. Claims need a package NDC.
Product NDC at billing width84725-0002Add 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
84725-002-0484725000204847250002047 BOTTLE in 1 CARTON (84725-002-04) / 60 mL in 1 BOTTLEMarketed from Sep 1, 2026
84725-002-10847250002108472500021028 BOTTLE in 1 CARTON (84725-002-10) / 60 mL in 1 BOTTLEMarketed from Sep 1, 2026

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 — 4 g/60mL
Dosage form
Suspension
Route
Rectal
Labeler
KLM Laboratories Private LimitedNDC labeler code 84725
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 220016
Marketing start
Listing expires
Other FDA classes
Aminosalicylic Acids (Chemical structure)
Identifiers
Product ID 84725-002_219908d6-9f7b-4fb0-8f14-009b1d783c9fSPL ID 219908d6-9f7b-4fb0-8f14-009b1d783c9f
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

N484725000204 followed by a unit qualifier and the quantity

Package 84725-0002-04. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 84725-002

What is NDC 84725-002?
84725-002 is the product NDC for Mesalamine, Mesalamine 4 g/60mL suspension, listed with the FDA by KLM Laboratories Private Limited. 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?
KLM Laboratories Private Limited, NDC labeler code 84725. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MesalamineMesalamine 250 mg/1Capsule, Extended releaseOralSandoz Inc0781-279100781-2791-64
MesalamineMesalamine 500 mg/1Capsule, Extended releaseOralSandoz Inc0781-279300781-2793-72
MesalamineMesalamine 1.2 g/1Tablet, Delayed releaseOralNuvaila Limited84612-17584612-0175-13
MesalamineMesalamine 4 g/60mLSuspensionRectalANI Pharmaceuticals, Inc.70954-30170954-0301-20
MesalamineMesalamine 375 mg/1Capsule, Extended releaseOralCamber Pharmaceuticals, Inc.31722-48931722-0489-12
MesalamineMesalamine 1000 mg/1SuppositoryRectalRising Pharma Holdings, Inc.16571-24616571-0246-0316571-0246-72
MesalamineMesalamine 800 mg/1Tablet, Delayed releaseOralAmneal Pharmaceuticals LLC65162-36065162-0360-18
MesalamineMesalamine 1.2 g/1Tablet, Delayed releaseOralNorthStar RxLLC72603-30472603-0304-01
MesalamineMesalamine 800 mg/1Tablet, Delayed releaseOralAvKARE42291-48942291-0489-18
MesalamineMesalamine .375 g/1Capsule, Extended releaseOralIngenus Pharmaceuticals, LLC50742-37150742-0371-12

All 59 Mesalamine NDCs

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in