Prescription drug · ANDA
Oxybutynin Chloride NDC 27241-155
Oxybutynin chloride 5 mg/1 · Tablet, Extended release · Oral · Ajanta Pharma USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27241-155-04 | 27241015504 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-155-04)Marketed from Feb 28, 2019 | |
| 27241-155-08 | 27241015508 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-155-08)Marketed from Feb 28, 2019 |
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
- Ajanta Pharma USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211655
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 27241-155_7513158b-c4a4-4e1a-b329-55ee91c5569eSPL ID 7513158b-c4a4-4e1a-b329-55ee91c5569eSPL set ID 95c2a144-ba0d-4011-ae0f-0e0ca876e8a8RxCUI 863619, 863628, 863636UNII L9F3D9RENQUPC 0327241156045, 0327241155048, 0327241157042
- 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
N427241015504followed by a unit qualifier and the quantityPackage 27241-0155-04. 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)
Oxybutynin chloride is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets is 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 is 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 pediatric patients aged 6 years and older with symp…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211655
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 10 mg/1 | Tablet, Extended releaseOral | Ajanta Pharma USA Inc. | 27241-156 |
| Oxybutynin Chloride | Oxybutynin chloride 15 mg/1 | Tablet, Extended releaseOral | Ajanta Pharma USA Inc. | 27241-157 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1599 |
| Oxybutynin Chloride | Oxybutynin chloride 15 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1600 |
| Oxybutynin Chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-1690 |