Prescription drug · ANDA
Mesalamine NDC 0832-6056
Mesalamine .375 g/1 · Capsule, Extended release · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0832-6056-12 | 00832605612 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-6056-12)Marketed from Jul 25, 2023 |
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 — .375 g/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217533
- Marketing start
- Listing expires
- Other FDA classes
- Aminosalicylic Acids (Chemical structure)
- Identifiers
- Product ID 0832-6056_44e0cd4f-abe7-5e61-e063-6294a90a988bSPL ID 44e0cd4f-abe7-5e61-e063-6294a90a988bSPL set ID 1e6978d0-01db-477d-a90f-27561777480fRxCUI 825130UNII 4Q81I59GXCUPC 0308326056122
- 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
N400832605612followed by a unit qualifier and the quantityPackage 00832-6056-12. 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.
Other NDCs under ANDA 217533
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 | Golden State Medical Supply, Inc. | 51407-976 |