Prescription drug · ANDA
Mesalamine NDC 31722-489
Mesalamine 375 mg/1 · Capsule, Extended release · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-489-12 | 3172204891231722048912 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-489-12)Marketed from Aug 13, 2025 |
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 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219864
- Marketing start
- Listing expires
- Other FDA classes
- Aminosalicylic Acids (Chemical structure)
- Identifiers
- Product ID 31722-489_4597df51-7ed6-14f4-e063-6294a90afb23SPL ID 4597df51-7ed6-14f4-e063-6294a90afb23SPL set ID ef471372-8d9f-4d95-9371-44522c69058fRxCUI 825130UNII 4Q81I59GXCUPC 0331722489126
- 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
N431722048912followed by a unit qualifier and the quantityPackage 31722-0489-12. 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 maintenance of remission of ulcerative colitis in adults. Mesalamine extended-release capsules are an aminosalicylate indicated for the maintenance of remission of ulcerative colitis in adults. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 31722-489
- What is NDC 31722-489?
- 31722-489 is the product NDC for Mesalamine, Mesalamine 375 mg/1 capsule, extended release, listed with the FDA by Camber Pharmaceuticals, 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?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 4 g/60mL | SuspensionRectal | KLM Laboratories Private Limited | 84725-002 | 84725-0002-0484725-0002-10 |
| Mesalamine | Mesalamine 250 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2791 | 00781-2791-64 |
| Mesalamine | Mesalamine 500 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2793 | 00781-2793-72 |
| 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 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 |