Prescription drug · ANDA
oxybutynin chloride NDC 72789-049
Oxybutynin chloride 10 mg/1 · Tablet, Extended release · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-049-90 | 72789004990 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-049-90)Marketed from Jan 28, 2020 |
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 — 10 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207138
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 72789-049_4af5faa0-1358-7489-e063-6294a90aae4eSPL ID 4af5faa0-1358-7489-e063-6294a90aae4eSPL set ID a1f8be75-2eb9-4eef-8fb4-144ef2bf7ae1RxCUI 863619UNII L9F3D9RENQUPC 0372789049908
- 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
N472789004990followed by a unit qualifier and the quantityPackage 72789-0049-90. 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 o…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207138
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 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-5822 |
| oxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-4307 |
| oxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-9689 |
| oxybutynin chloride | Oxybutynin chloride 15 mg/1 | Tablet, Extended releaseOral | Accord Healthcare, Inc. | 16729-319 |
| oxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Accord Healthcare, Inc. | 16729-317 |
| oxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | Accord Healthcare, Inc. | 16729-318 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | direct rx | 72189-131 |
| Oxybutynin Chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | DIRECT RX | 72189-132 |
| oxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-667 |