Prescription drug · ANDA
Oxybutynin Chloride NDC 68788-8141
Oxybutynin chloride 5 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8141-9 | 68788814109 | 90 TABLET in 1 BOTTLE, PLASTIC (68788-8141-9)Marketed from Feb 11, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209335
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 68788-8141_c96411f4-50fe-42a7-9463-5bb9d2939ac3SPL ID c96411f4-50fe-42a7-9463-5bb9d2939ac3SPL set ID 0e002fe8-fa3f-4a7d-84df-0c6e031e6ae4RxCUI 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
N468788814109followed by a unit qualifier and the quantityPackage 68788-8141-09. 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 209335
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 | PD-Rx Pharmaceuticals, Inc. | 43063-851 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-4622 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-931 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1494 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-047 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2640 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | KVK-Tech, Inc. | 10702-201 |