Prescription drug · ANDA
Mesalamine NDC 0093-5907
Mesalamine 400 mg/1 · Capsule, Delayed release · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-5907-86 | 00093590786 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-5907-86)Marketed from May 9, 2019 |
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 — 400 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207873
- Marketing start
- Listing expires
- Other FDA classes
- Aminosalicylic Acids (Chemical structure)
- Identifiers
- Product ID 0093-5907_5c416cce-8cdd-4ce2-834d-19783189b85eSPL ID 5c416cce-8cdd-4ce2-834d-19783189b85eSPL set ID 6fd0a906-e1b5-4238-a79b-a195510ddc84RxCUI 1368954UNII 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
N400093590786followed by a unit qualifier and the quantityPackage 00093-5907-86. 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 delayed-release capsules are an aminosalicylate indicated for: Treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. ( 1.1 ) Maintenance of remission of ulcerative colitis in adults. ( 1.2 ) 1.1 Treatment of Mildly to Moderately Active Ulcerative Colitis Mesalamine delayed-release capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. 1.2 Maintenance of Remission of Ulcerative Colitis Mesalamine delayed-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
Excerpt only. Read the full label for complete information.