Prescription drug · ANDA
Mesalamine NDC 64980-282
Mesalamine 1000 mg/1 · Suppository · Rectal · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-282-03 | 64980028203 | 5 PACKAGE in 1 CARTON (64980-282-03) / 6 SUPPOSITORY in 1 PACKAGEMarketed from Jun 5, 2019 |
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 — 1000 mg/1
- Dosage form
- Suppository
- Route
- Rectal
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207448
- Marketing start
- Marketing end
- Other FDA classes
- Aminosalicylic Acids (Chemical structure)
- Identifiers
- Product ID 64980-282_18f268ab-16e6-4456-8e7d-42b30ccf82afSPL ID 18f268ab-16e6-4456-8e7d-42b30ccf82afSPL set ID de981df1-747a-480d-a866-e72332a1544dRxCUI 248420UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N464980028203followed by a unit qualifier and the quantityPackage 64980-0282-03. 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 suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. Mesalamine suppositories are an aminosalicylate indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207448
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 1000 mg/1 | SuppositoryRectal | Bryant Ranch Prepack | 72162-1804 |
| Mesalamine | Mesalamine 1000 mg/1 | SuppositoryRectal | Bryant Ranch Prepack | 63629-2397 |