Prescription drug · ANDA
Mesalamine NDC 67877-717
Mesalamine .375 g/1 · Capsule, Extended release · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-717-05 | 6787707170567877071705 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (67877-717-05)Marketed from Jul 16, 2021 | |
| 67877-717-12 | 6787707171267877071712 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (67877-717-12)Marketed from Jul 16, 2021 |
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
- Ascend Laboratories, LLCNDC labeler code 67877
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214242
- Marketing start
- Listing expires
- Other FDA classes
- Aminosalicylic Acids (Chemical structure)
- Identifiers
- Product ID 67877-717_2eece16c-6316-4dc0-bf4f-25a3f1c08ae5SPL ID 2eece16c-6316-4dc0-bf4f-25a3f1c08ae5SPL set ID 43f69db3-81ac-4da4-a61f-fbba6299d9c2RxCUI 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
N467877071705followed by a unit qualifier and the quantityPackage 67877-0717-05. 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 67877-717
- What is NDC 67877-717?
- 67877-717 is the product NDC for Mesalamine, Mesalamine .375 g/1 capsule, extended release, listed with the FDA by Ascend Laboratories, LLC. 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?
- Ascend Laboratories, LLC, NDC labeler code 67877. 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 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 214242
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 | AvPAK | 50268-577 |
| Mesalamine | Mesalamine .375 g/1 | Capsule, Extended releaseOral | American Health Packaging | 60687-650 |