Prescription drug · ANDA
Oxybutynin Chloride NDC 52817-261
Oxybutynin chloride 2.5 mg/1 · Tablet · Oral · TruPharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52817-261-10 | 52817026110 | 100 TABLET in 1 BOTTLE, PLASTIC (52817-261-10)Marketed from Jul 28, 2026 |
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 — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TruPharma LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210125
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 52817-261_57a1be6c-ccda-bbd3-e063-6394a90a34d8SPL ID 57a1be6c-ccda-bbd3-e063-6394a90a34d8SPL set ID 7c497c6c-2448-2c80-e053-2991aa0ab8c7RxCUI 863664, 863758UNII L9F3D9RENQUPC 0352817260505, 0352817261106, 0352817260109
- 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
N452817026110followed by a unit qualifier and the quantityPackage 52817-0261-10. 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 210125
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 | TruPharma LLC | 52817-260 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-394 |