Prescription drug · ANDA
Oxybutynin Chloride NDC 64980-431
Oxybutynin chloride 5 mg/1 · Tablet · Oral · RISING PHARMA HOLDINGS, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-431-01 | 64980043101 | 100 TABLET in 1 BOTTLE (64980-431-01)Marketed from Feb 1, 2018 | |
| 64980-431-10 | 64980043110 | 1000 TABLET in 1 BOTTLE (64980-431-10)Marketed from Feb 1, 2018 | |
| 64980-431-50 | 64980043150 | 500 TABLET in 1 BOTTLE (64980-431-50)Marketed from Feb 1, 2018 |
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
- RISING PHARMA HOLDINGS, INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209025
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 64980-431_92fdb885-c818-4c39-909a-7f2f53840d90SPL ID 92fdb885-c818-4c39-909a-7f2f53840d90SPL set ID f8ed80f2-6c3d-4d7f-b761-c2447973c1f9RxCUI 863664, 863758UNII L9F3D9RENQUPC 0364980431507, 0364980431019, 0364980531016, 0364980431101
- 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
N464980043101followed by a unit qualifier and the quantityPackage 64980-0431-01. 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 is 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 209025
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 | A-S Medication Solutions | 50090-6638 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-490 |
| Oxybutynin Chloride | Oxybutynin chloride 2.5 mg/1 | TabletOral | RISING PHARMA HOLDINGS, INC. | 64980-531 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1014 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | RISING PHARMA HOLDINGS, INC. | 64980-679 |
| Oxybutynin Chloride | Oxybutynin chloride 2.5 mg/1 | TabletOral | RISING PHARMA HOLDINGS, INC. | 64980-734 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7766 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-417 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-8078 |