Prescription drug · ANDA
Trospium Chloride NDC 69097-912
Trospium chloride 20 mg/1 · Tablet, Film coated · Oral · CIPLA USA INC.,
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-912-02 | 69097091202 | 30 TABLET, FILM COATED in 1 BOTTLE (69097-912-02)Marketed from Sep 23, 2016 | |
| 69097-912-03 | 69097091203 | 60 TABLET, FILM COATED in 1 BOTTLE (69097-912-03)Marketed from Sep 23, 2016 | |
| 69097-912-15 | 69097091215 | 1000 TABLET, FILM COATED in 1 BOTTLE (69097-912-15)Marketed from Sep 23, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- CIPLA USA INC.,
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091688
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 69097-912_9058b0be-0e24-418e-9be7-597c00fe8b70SPL ID 9058b0be-0e24-418e-9be7-597c00fe8b70SPL set ID 6a711666-9e80-4728-b745-e7dc86f57510RxCUI 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
N469097091202followed by a unit qualifier and the quantityPackage 69097-0912-02. 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 091688
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 | Exelan Pharmaceuticals Inc. | 76282-336 |