Prescription drug · ANDA
Trospium Chloride NDC 0904-7059
Trospium chloride 20 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7059-52 | 00904705952 | 60 TABLET, FILM COATED in 1 BOTTLE (0904-7059-52)Marketed from Nov 16, 2015 |
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)
- Trospium Chloride
- Generic name (nonproprietary)
- trospium chloride
- Active ingredients
- Trospium chloride — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204945
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 0904-7059_239e206f-f6ca-4b35-a5b0-46d255cd57faSPL ID 239e206f-f6ca-4b35-a5b0-46d255cd57faSPL set ID 35ae4d64-4625-4fdd-a2d4-e20b87c56876RxCUI 857560UNII 1E6682427E
- Pharmacologic class
- Cholinergic Muscarinic Antagonist
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
N400904705952followed by a unit qualifier and the quantityPackage 00904-7059-52. 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)
Trospium chloride tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Trospium chloride tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204945
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 |
|---|---|---|---|---|
| Trospium Chloride | Trospium chloride 20 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-742 |
| Trospium Chloride | Trospium chloride 20 mg/1 | Tablet, Film coatedOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-530 |
| Trospium Chloride | Trospium chloride 20 mg/1 | Tablet, Film coatedOral | MAJOR PHARMACEUTICALS | 0904-7619 |
| Trospium Chloride | Trospium chloride 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-812 |
| Trospium Chloride | Trospium chloride 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4593 |