Prescription drug · ANDA
Oxybutynin Chloride NDC 67046-1600
Oxybutynin chloride 15 mg/1 · Tablet, Extended release · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1600-3 | 6704616000367046160003 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1600-3)Marketed from Sep 23, 2025 |
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 — 15 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Coupler LLCNDC labeler code 67046
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211655
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 67046-1600_46b2b02c-85d8-8404-e063-6294a90a0eefSPL ID 46b2b02c-85d8-8404-e063-6294a90a0eefSPL set ID 3f7dc283-b168-8251-e063-6294a90a45a2RxCUI 863628UNII 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
N467046160003followed by a unit qualifier and the quantityPackage 67046-1600-03. 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 is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets is 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). Oxybutynin chloride is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ( 1 ) Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symp…
Excerpt only. Read the full label for complete information.
About NDC 67046-1600
- What is NDC 67046-1600?
- 67046-1600 is the product NDC for Oxybutynin Chloride, Oxybutynin chloride 15 mg/1 tablet, extended release, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxybutynin Chloride.
- What is the active ingredient?
- Oxybutynin chloride.
- Who is the labeler?
- Coupler LLC, NDC labeler code 67046. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Oxybutynin Chloride?
- 79 other product NDCs are listed under this name. See all Oxybutynin Chloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oxybutynin Chloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Oxybutynin Chloride | Oxybutynin chloride 2.5 mg/1 | TabletOral | TruPharma LLC | 52817-261 | 52817-0261-10 |
| Oxybutynin Chloride | Oxybutynin chloride 2.5 mg/1 | TabletOral | RISING PHARMA HOLDINGS, INC. | 64980-734 | 64980-0734-01 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | Coupler LLC | 67046-1381 | 67046-1381-03 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-913 | 23155-0913-0123155-0913-0523155-0913-10 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | RISING PHARMA HOLDINGS, INC. | 64980-679 | 64980-0679-0164980-0679-1064980-0679-50 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-8078 | 50090-8078-0050090-8078-0150090-8078-03 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | American Health Packaging | 60687-899 | 60687-0899-01 |
| Oxybutynin Chloride | Oxybutynin chloride 2.5 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-190 | 64380-0190-01 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1599 | 67046-1599-03 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | AvKARE | 42291-456 | 42291-0456-50 |
Other NDCs under ANDA 211655
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 | Tablet, Extended releaseOral | Ajanta Pharma USA Inc. | 27241-155 |
| Oxybutynin Chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | Ajanta Pharma USA Inc. | 27241-156 |
| Oxybutynin Chloride | Oxybutynin chloride 15 mg/1 | Tablet, Extended releaseOral | Ajanta Pharma USA Inc. | 27241-157 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1599 |
| Oxybutynin Chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-1690 |