Prescription drug · ANDA
Mesalamine NDC 0527-3012
Mesalamine 1.2 g/1 · Tablet, Delayed release · Oral · Lannett Company Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-3012-48 | 00527301248 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0527-3012-48)Marketed from Jun 3, 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 — 1.2 g/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Lannett Company Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217337
- Marketing start
- Listing expires
- Other FDA classes
- Aminosalicylic Acids (Chemical structure)
- Identifiers
- Product ID 0527-3012_81f0e9e6-e117-46fa-b0e6-c423f63bd3d3SPL ID 81f0e9e6-e117-46fa-b0e6-c423f63bd3d3SPL set ID 29dbe417-15a9-4c4d-846b-81cabda7ac70RxCUI 686429UNII 4Q81I59GXCUPC 0305273012485
- 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
N400527301248followed by a unit qualifier and the quantityPackage 00527-3012-48. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.