Prescription drug · ANDA
oxybutynin NDC 50090-5353
Oxybutynin chloride 10 mg/1 · Tablet, Film coated, Extended release · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5353-0 | 5009053530050090535300 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5353-0)Marketed from Nov 11, 2020 |
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 — 10 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- 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 50090-5353_2d660e74-e22d-4493-9e7b-51c8031c3c69SPL ID 2d660e74-e22d-4493-9e7b-51c8031c3c69SPL set ID 1f95920c-5dc2-44e4-b61d-b2c5e05390baRxCUI 863619UNII 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
N450090535300followed by a unit qualifier and the quantityPackage 50090-5353-00. 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)
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 symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). ( 1 ) Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended release tablets are also indicated for the treatment of pediatric patients…
Excerpt only. Read the full label for complete information.
About NDC 50090-5353
- What is NDC 50090-5353?
- 50090-5353 is the product NDC for oxybutynin, Oxybutynin chloride 10 mg/1 tablet, film coated, extended release, listed with the FDA by A-S Medication Solutions. 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?
- A-S Medication Solutions, NDC labeler code 50090. 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 5 mg/1 | Tablet, Film coated, Extended releaseOral | Redpharm Drug | 67296-2335 | 67296-2335-03 |
| 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 5 mg/1 | Tablet, Film coated, Extended releaseOral | Redpharm Drug | 67296-2335 |
| 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 |