Prescription drug · ANDA
Mesalamine NDC 60687-397
Mesalamine 1.2 g/1 · Tablet, Delayed release · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-397-25 | 6068703972560687039725 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-397-25) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-397-95)Marketed from Oct 11, 2018 |
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 — 1.2 g/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- American Health PackagingNDC labeler code 60687
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091640
- Marketing start
- Listing expires
- Other FDA classes
- Aminosalicylic Acids (Chemical structure)
- Identifiers
- Product ID 60687-397_278689c8-9371-59ed-e063-6294a90a7bdaSPL ID 278689c8-9371-59ed-e063-6294a90a7bdaSPL set ID 77140634-9f32-40ca-8c83-9fcc3e373c16RxCUI 686429UNII 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
N460687039725followed by a unit qualifier and the quantityPackage 60687-0397-25. 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 delayed-release tablets are indicated for the: induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. Mesalamine delayed-release tablets are an aminosalicylate indicated for the induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. (1) treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. (1)
Excerpt only. Read the full label for complete information.
About NDC 60687-397
- What is NDC 60687-397?
- 60687-397 is the product NDC for Mesalamine, Mesalamine 1.2 g/1 tablet, delayed release, listed with the FDA by American Health Packaging. 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?
- American Health Packaging, NDC labeler code 60687. 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 091640
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 1.2 g/1 | Tablet, Delayed releaseOral | Major Pharmaceuticals | 0904-6832 |
| mesalamine | Mesalamine 1.2 g/1 | Tablet, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-900 |
| mesalamine | Mesalamine 1.2 g/1 | Tablet, Delayed releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-711 |
| mesalamine | Mesalamine 1.2 g/1 | Tablet, Delayed releaseOral | Zydus Lifesciences Limited | 70771-1071 |