Prescription drug · ANDA
Trospium Chloride NDC 0574-0145
Trospium chloride 20 mg/1 · Tablet, Film coated · Oral · Padagis US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0574-0145-60 | 00574014560 | 60 TABLET, FILM COATED in 1 BOTTLE (0574-0145-60)Marketed from Nov 17, 2010 |
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
- Padagis US LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091573
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 0574-0145_89cdc3a1-78f6-49df-ae6c-91205463fc63SPL ID 89cdc3a1-78f6-49df-ae6c-91205463fc63SPL set ID bb3284ee-3d13-41c7-8e4b-f9b2d44350daRxCUI 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
N400574014560followed by a unit qualifier and the quantityPackage 00574-0145-60. 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 091573
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 | Bryant Ranch Prepack | 63629-8457 |
| Trospium Chloride | Trospium chloride 20 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-348 |
| Trospium Chloride | Trospium chloride 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2961 |
| Trospium Chloride | Trospium chloride 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1108 |
| Trospium Chloride | Trospium chloride 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-9279 |