Over-the-counter drug · NDA
Oxytrol for Women (oxybutynin) NDC 0023-9637
Oxybutynin 3.9 mg/d · Patch · Transdermal · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0023-9637-04 | 00023963704 | 16 PATCH in 1 CARTON (0023-9637-04) / 4 d in 1 PATCHMarketed from Jan 1, 2016 | |
| 0023-9637-08 | 00023963708 | 32 PATCH in 1 CARTON (0023-9637-08) / 4 d in 1 PATCHMarketed from Oct 1, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Oxytrol for Women
- Generic name (nonproprietary)
- oxybutynin
- Active ingredients
- Oxybutynin — 3.9 mg/d
- Dosage form
- Patch
- Route
- Transdermal
- Labeler
- Allergan, Inc.
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202211
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 0023-9637_cc404430-2345-4294-8efc-e1e996cc17b2SPL ID cc404430-2345-4294-8efc-e1e996cc17b2SPL set ID 8cdc5b4d-ff8d-4010-97d7-313422a0b868RxCUI 403799, 404448UNII K9P6MC7092
- 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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400023963704followed by a unit qualifier and the quantityPackage 00023-9637-04. 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)
Use treats overactive bladder in women you may be suffering from overactive bladder if you have had 2 or more of the following symptoms for at least 3 months: ○ urinary frequency (the need to urinate more often than usual; typically more than 8 times in 24 hours) ○ urinary urgency (a strong need to urinate right away) ○ urge incontinence (leaking or wetting yourself if you cannot control the urge to urinate) non-drug therapies may also help you (see the consumer information leaflet inside the package)
Excerpt only. Read the full label for complete information.