Prescription drug · ANDA
Oxybutynin Chloride NDC 65162-371
Oxybutynin chloride 5 mg/1 · Tablet, Extended release · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-371-03 | 65162037103 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-03)Marketed from Nov 2, 2015 | |
| 65162-371-09 | 65162037109 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-09)Marketed from Nov 2, 2015 | |
| 65162-371-10 | 65162037110 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-10)Marketed from Nov 2, 2015 | |
| 65162-371-50 | 65162037150 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-50)Marketed from Nov 2, 2015 |
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
- Generic name (nonproprietary)
- oxybutynin chloride
- Active ingredients
- Oxybutynin chloride — 5 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204010
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 65162-371_25b959bc-5b59-4c9c-b7a0-ae475a8e0290SPL ID 25b959bc-5b59-4c9c-b7a0-ae475a8e0290SPL set ID 53924eba-1919-4203-9a1e-d57dfdd3b963RxCUI 863619, 863628, 863636UNII L9F3D9RENQUPC 0365162371031, 0365162372038, 0365162373035
- 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
N465162037103followed by a unit qualifier and the quantityPackage 65162-0371-03. 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 204010
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 | Amneal Pharmaceuticals LLC | 65162-373 |
| Oxybutynin Chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-372 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Major Pharmaceuticals | 0904-6570 |