NDC codes

FDA NDC Directory
Product NDC (as listed)0781-2793Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-2793Add 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
0781-2793-7200781279372120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2793-72)Marketed from Jul 15, 2026

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 500 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Labeler
Sandoz IncNDC labeler code 0781
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 219997
Marketing start
Listing expires
Other FDA classes
Aminosalicylic Acids (Chemical structure)
Identifiers
Product ID 0781-2793_52d8e30f-56bb-4822-8c6b-448ca3cd1923SPL ID 52d8e30f-56bb-4822-8c6b-448ca3cd1923SPL set ID 47b5d1ee-b439-4ccb-9b01-c0875ccd748aRxCUI 314092, 476362UNII 4Q81I59GXCUPC 0307812791646
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

N400781279372 followed by a unit qualifier and the quantity

Package 00781-2793-72. 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 .

Indications (excerpt from the label)

Mesalamine extended-release capsules are indicated for the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients. Mesalamine is an aminosalicylate indicated for the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-2793

What is NDC 0781-2793?
0781-2793 is the product NDC for Mesalamine, Mesalamine 500 mg/1 capsule, extended release, listed with the FDA by Sandoz 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?
Sandoz Inc, NDC labeler code 0781. 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 1.2 g/1Tablet, Delayed releaseOralNuvaila Limited84612-17584612-0175-13
MesalamineMesalamine 4 g/60mLSuspensionRectalANI Pharmaceuticals, Inc.70954-30170954-0301-20
MesalamineMesalamine 4 g/60mLSuspensionRectalKLM Laboratories Private Limited84725-00284725-0002-03
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

Other NDCs under ANDA 219997

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

FDA NDC Directory listings under ANDA 219997
ProductStrengthForm · routeLabelerProduct NDC
MesalamineMesalamine 250 mg/1Capsule, Extended releaseOralSandoz Inc0781-2791

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