Prescription drug · ANDA
Oxybutynin Chloride Extended Release NDC 42291-634
oxybutynin chloride · Oxybutynin chloride 10 mg/1 · Tablet, Extended release · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-634-01 | 42291063401 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-634-01)Marketed from Mar 9, 2016 | |
| 42291-634-50 | 42291063450 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-634-50)Marketed from Mar 9, 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)
- Oxybutynin Chloride Extended ReleaseSuffix: Extended Release
- Generic name (nonproprietary)
- oxybutynin chloride
- Active ingredients
- Oxybutynin chloride — 10 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078503
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 42291-634_46143c62-4276-2b49-e063-6294a90ae1aaSPL ID 46143c62-4276-2b49-e063-6294a90ae1aaSPL set ID 94471401-a516-0fe7-ec9c-447dd2bee972RxCUI 863619, 863628, 863636UNII L9F3D9RENQUPC 0342291635012, 0342291633018, 0342291634503, 0342291633506
- 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
N442291063401followed by a unit qualifier and the quantityPackage 42291-0634-01. 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)
Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (1) Oxybutynin chloride extended-release tablets are also indicated for the treatment of …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078503
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 |
|---|---|---|---|---|
| oxybutynin chloride | Oxybutynin chloride 15 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-509 |
| oxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-507 |
| oxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-508 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | American Health Packaging | 68084-480 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 15 mg/1 | Tablet, Extended releaseOral | AvPAK | 50268-629 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | AvPAK | 50268-627 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | AvPAK | 50268-628 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-282 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-284 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | American Health Packaging | 68084-610 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-285 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 15 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-322 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | AvKARE | 42291-633 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 15 mg/1 | Tablet, Extended releaseOral | AvKARE | 42291-635 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Lannett Company, Inc. | 62175-270 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | Lannett Company, Inc. | 62175-271 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 15 mg/1 | Tablet, Extended releaseOral | Lannett Company, Inc. | 62175-272 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 43063-790 |