Prescription drug · ANDA
Mesalamine NDC 0781-2793
Mesalamine 500 mg/1 · Capsule, Extended release · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-2793-72 | 00781279372 | 120 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
N400781279372followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Mesalamine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mesalamine | Mesalamine 250 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2791 | 00781-2791-64 |
| 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 4 g/60mL | SuspensionRectal | KLM Laboratories Private Limited | 84725-002 | 84725-0002-03 |
| Mesalamine | Mesalamine 375 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-489 | 31722-0489-12 |
| Mesalamine | Mesalamine 1000 mg/1 | SuppositoryRectal | Rising Pharma Holdings, Inc. | 16571-246 | 16571-0246-0316571-0246-72 |
| 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 |
Other NDCs under ANDA 219997
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Mesalamine | Mesalamine 250 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2791 |