Prescription drug · ANDA
Oxybutynin Chloride NDC 42291-456
Oxybutynin chloride 5 mg/1 · Tablet · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-456-50 | 42291045650 | 500 TABLET in 1 BOTTLE (42291-456-50)Marketed from May 1, 2025 |
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
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208165
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 42291-456_3418aa43-c59d-8e55-e063-6394a90ae7e1SPL ID 3418aa43-c59d-8e55-e063-6394a90ae7e1SPL set ID 3418ca19-feb0-9821-e063-6394a90ae819RxCUI 863664UNII L9F3D9RENQ
- 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
N442291045650followed by a unit qualifier and the quantityPackage 42291-0456-50. 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)
INDICATIONS AND USAGE Oxybutynin chloride tablets are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208165
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 5 mg/1 | TabletOral | Coupler LLC | 67046-1381 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | American Health Packaging | 60687-899 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-810 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-781 |