Prescription drug · ANDA
Oxybutynin Chloride NDC 72189-130
Oxybutynin chloride 5 mg/1 · Tablet · Oral · direct rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-130-30 | 72189013030 | 30 TABLET in 1 BOTTLE (72189-130-30)Marketed from Nov 11, 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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- direct rx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071655
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 72189-130_2bece08b-b60b-a15e-e063-6394a90a3a13SPL ID 2bece08b-b60b-a15e-e063-6394a90a3a13SPL set ID b3d6d2a8-97c4-5bad-e053-2a95a90a155dRxCUI 863636, 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
N472189013030followed by a unit qualifier and the quantityPackage 72189-0130-30. 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 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).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 071655
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 | Proficient Rx LP | 63187-749 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0519 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 50111-456 |