Prescription drug · ANDA
Mesalamine NDC 62332-724
Mesalamine .375 g/1 · Capsule, Extended release · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-724-35 | 62332072435 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-724-35)Marketed from Nov 3, 2022 | |
| 62332-724-91 | 62332072491 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-724-91)Marketed from Nov 3, 2022 |
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
- Labeler
- Alembic Pharmaceuticals Inc.NDC labeler code 62332
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216967
- Marketing start
- Listing expires
- Other FDA classes
- Aminosalicylic Acids (Chemical structure)
- Identifiers
- Product ID 62332-724_7d9111a9-c8be-4823-b104-badc44eb08a5SPL ID 7d9111a9-c8be-4823-b104-badc44eb08a5SPL set ID 87d3d62d-2dc3-4e6f-be33-cabbca12e8f7RxCUI 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
N462332072435followed by a unit qualifier and the quantityPackage 62332-0724-35. 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 capsule is 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 62332-724
- What is NDC 62332-724?
- 62332-724 is the product NDC for Mesalamine, Mesalamine .375 g/1 capsule, extended release, listed with the FDA by Alembic Pharmaceuticals Inc.. 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?
- Alembic Pharmaceuticals Inc., NDC labeler code 62332. 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 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 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 |
Other NDCs under ANDA 216967
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 .375 g/1 | Capsule, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-724 |