Prescription drug · ANDA
Mesalamine NDC 31722-005
Mesalamine 1000 mg/1 · Suppository · Rectal · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-005-30 | 31722000530 | 5 PACKAGE in 1 CARTON (31722-005-30) / 6 SUPPOSITORY in 1 PACKAGE (31722-005-32)Marketed from Mar 19, 2020 | |
| 31722-005-31 | 31722000531 | 7 PACKAGE in 1 CARTON (31722-005-31) / 6 SUPPOSITORY in 1 PACKAGE (31722-005-32)Marketed from Mar 19, 2020 |
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
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213377
- Marketing start
- Listing expires
- Other FDA classes
- Aminosalicylic Acids (Chemical structure)
- Identifiers
- Product ID 31722-005_1248c2d3-b241-5551-e063-6294a90a2f4eSPL ID 1248c2d3-b241-5551-e063-6294a90a2f4eSPL set ID efa9d039-ae1f-4cd6-98f2-e87a901dfaebRxCUI 248420UNII 4Q81I59GXCUPC 0331722005302, 0331722005319
- 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
N431722000530followed by a unit qualifier and the quantityPackage 31722-0005-30. 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. ( 1 )
Excerpt only. Read the full label for complete information.