Prescription drug · NDA AUTHORIZED GENERIC
mesalamine NDC 0093-9224
Mesalamine 375 mg/1 · Capsule, Extended release · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-9224-89 | 00093922489 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-9224-89)Marketed from Jan 5, 2021 |
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 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022301
- Marketing start
- Listing expires
- Other FDA classes
- Aminosalicylic Acids (Chemical structure)
- Identifiers
- Product ID 0093-9224_0ce3f59e-e447-81a0-e063-6394a90ab0c3SPL ID 0ce3f59e-e447-81a0-e063-6394a90ab0c3SPL set ID 8d27a608-3ba1-4799-be38-c00fb08ce3ceRxCUI 825130UNII 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
N400093922489followed by a unit qualifier and the quantityPackage 00093-9224-89. 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 is 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 NDA 022301
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 |
|---|---|---|---|---|
| Aprisomesalamine | Mesalamine 375 mg/1 | Capsule, Extended releaseOral | Salix Pharmaceuticals, Inc. | 65649-103 |
| mesalamine | Mesalamine 375 mg/1 | Capsule, Extended releaseOral | Oceanside Pharmaceuticals | 68682-113 |