Prescription drug · ANDA
Oxybutynin Chloride NDC 0832-0038
Oxybutynin chloride 5 mg/1 · Tablet · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0832-0038-00 | 00832003800 | 100 TABLET in 1 BOTTLE (0832-0038-00)Marketed from Nov 7, 2011 | |
| 0832-0038-10 | 00832003810 | 1000 TABLET in 1 BOTTLE (0832-0038-10)Marketed from Nov 7, 2011 | |
| 0832-0038-50 | 00832003850 | 500 TABLET in 1 BOTTLE (0832-0038-50)Marketed from Nov 7, 2011 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074625
- Marketing start
- Marketing end
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 0832-0038_45af3420-b44f-39a1-e063-6394a90ad626SPL ID 45af3420-b44f-39a1-e063-6394a90ad626SPL set ID 3ee6835a-7a7d-49a9-8460-2f1dd270ead3RxCUI 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
N400832003800followed by a unit qualifier and the quantityPackage 00832-0038-00. 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 tablets, USP are 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 074625
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 | Aphena Pharma Solutions - Tennessee, LLC | 43353-978 |