Prescription drug · ANDA
Trospium Chloride ER (Trospium chloride) NDC 63629-8458
Trospium chloride 60 mg/1 · Capsule, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8458-1 | 6362984580163629845801 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8458-1)Marketed from Feb 9, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 ERSuffix: ER
- Generic name (nonproprietary)
- trospium chloride
- Active ingredients
- Trospium chloride — 60 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201291
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 63629-8458_92fd6281-041a-461a-902d-e42f4b8821edSPL ID 92fd6281-041a-461a-902d-e42f4b8821edSPL set ID 2f431dd1-e130-45e5-a796-1662f498585eRxCUI 857564UNII 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
N463629845801followed by a unit qualifier and the quantityPackage 63629-8458-01. 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 Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Trospium Chloride Extended-Release Capsules 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.
About NDC 63629-8458
- What is NDC 63629-8458?
- 63629-8458 is the product NDC for Trospium Chloride ER (trospium chloride), Trospium chloride 60 mg/1 capsule, extended release, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Trospium Chloride ER (Trospium Chloride).
- What is the active ingredient?
- Trospium chloride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Trospium Chloride ER?
- 3 other product NDCs are listed under this name. See all Trospium Chloride ER NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Trospium Chloride ER products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Trospium Chloride ERtrospium chloride | Trospium chloride 60 mg/1 | Capsule, Extended releaseOral | Padagis US LLC | 0574-0118 | 00574-0118-30 |
| Trospium Chloride ERtrospium chloride | Trospium chloride 60 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-2931 | 71335-2931-01 |
| Trospium Chloride ERtrospium chloride | Trospium chloride 60 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 72162-1106 | 72162-1106-0172162-1106-03 |
Other NDCs under ANDA 201291
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 ERtrospium chloride | Trospium chloride 60 mg/1 | Capsule, Extended releaseOral | Padagis US LLC | 0574-0118 |
| Trospium Chloride ERtrospium chloride | Trospium chloride 60 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-2931 |
| Trospium Chloride ERtrospium chloride | Trospium chloride 60 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 72162-1106 |