Prescription drug · ANDA
oxybutynin NDC 67296-2335
Oxybutynin chloride 5 mg/1 · Tablet, Film coated, Extended release · Oral · Redpharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-2335-3 | 6729623350367296233503 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67296-2335-3)Marketed from Aug 10, 2017 |
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
- Generic name (nonproprietary)
- oxybutynin
- Active ingredients
- Oxybutynin chloride — 5 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Redpharm DrugNDC labeler code 67296
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202332
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 67296-2335_5b432a71-51ef-8719-e063-6294a90a6511SPL ID 5b432a71-51ef-8719-e063-6294a90a6511
- 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
N467296233503followed by a unit qualifier and the quantityPackage 67296-2335-03. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 67296-2335
- What is NDC 67296-2335?
- 67296-2335 is the product NDC for oxybutynin, Oxybutynin chloride 5 mg/1 tablet, film coated, extended release, listed with the FDA by Redpharm Drug. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- oxybutynin.
- What is the active ingredient?
- Oxybutynin chloride.
- Who is the labeler?
- Redpharm Drug, NDC labeler code 67296. 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?
- 9 other product NDCs are listed under this name. See all oxybutynin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other oxybutynin 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 | Oxybutynin chloride 5 mg/1 | Tablet, Film coated, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8219 | 00615-8219-39 |
| oxybutynin | Oxybutynin chloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8220 | 00615-8220-39 |
| oxybutynin | Oxybutynin chloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-5353 | 50090-5353-00 |
| oxybutynin | Oxybutynin chloride 5 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-255 | 68382-0255-0168382-0255-0568382-0255-06+3 more |
| oxybutynin | Oxybutynin chloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-256 | 68382-0256-0168382-0256-0568382-0256-06+3 more |
| oxybutynin | Oxybutynin chloride 15 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-257 | 68382-0257-0168382-0257-0568382-0257-06+3 more |
| oxybutynin | Oxybutynin chloride 5 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 70771-1086 | 70771-1086-0170771-1086-0370771-1086-04+3 more |
| oxybutynin | Oxybutynin chloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 70771-1087 | 70771-1087-0170771-1087-0370771-1087-04+3 more |
| oxybutynin | Oxybutynin chloride 15 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 70771-1088 | 70771-1088-0170771-1088-0370771-1088-04+3 more |
Other NDCs under ANDA 202332
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 | Oxybutynin chloride 5 mg/1 | Tablet, Film coated, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8219 |
| oxybutynin | Oxybutynin chloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8220 |
| oxybutynin | Oxybutynin chloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-5353 |
| oxybutynin | Oxybutynin chloride 5 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-255 |
| oxybutynin | Oxybutynin chloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-256 |
| oxybutynin | Oxybutynin chloride 15 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-257 |
| oxybutynin | Oxybutynin chloride 5 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 70771-1086 |
| oxybutynin | Oxybutynin chloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 70771-1087 |
| oxybutynin | Oxybutynin chloride 15 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 70771-1088 |