Prescription drug · ANDA
Oxybutynin Chloride NDC 63187-749
Oxybutynin chloride 5 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-749-30 | 63187074930 | 30 TABLET in 1 BOTTLE (63187-749-30)Marketed from Oct 3, 2016 | |
| 63187-749-60 | 63187074960 | 60 TABLET in 1 BOTTLE (63187-749-60)Marketed from Oct 3, 2016 | |
| 63187-749-90 | 63187074990 | 90 TABLET in 1 BOTTLE (63187-749-90)Marketed from Oct 3, 2016 |
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
- Proficient Rx LP
- 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 63187-749_086f1e11-bff2-4f7b-9591-2ba9e1fdf217SPL ID 086f1e11-bff2-4f7b-9591-2ba9e1fdf217SPL set ID e3f0c249-8085-4979-823a-820e233a284fRxCUI 863664UNII L9F3D9RENQUPC 0363187749309
- 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
N463187074930followed by a unit qualifier and the quantityPackage 63187-0749-30. 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)
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 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 | Bryant Ranch Prepack | 71335-0519 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | direct rx | 72189-130 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 50111-456 |