Prescription drug · ANDA
Oxybutynin Chloride Extended Release (Oxybutynin chloride) NDC 68084-480
Oxybutynin chloride 5 mg/1 · Tablet, Extended release · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-480-01 | 6808404800168084048001 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-480-01) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-480-11)Marketed from Jan 13, 2012 | |
| 68084-480-65 | 6808404806568084048065 | 50 BLISTER PACK in 1 CARTON (68084-480-65) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-480-11)Marketed from Feb 21, 2023 |
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 Extended ReleaseSuffix: Extended Release
- Generic name (nonproprietary)
- oxybutynin chloride
- Active ingredients
- Oxybutynin chloride — 5 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- American Health PackagingNDC labeler code 68084
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078503
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 68084-480_55006678-3c42-0b82-e063-6394a90a1103SPL ID 55006678-3c42-0b82-e063-6394a90a1103SPL set ID 0c71bdfb-01db-49ac-a8e9-0037df0d24afRxCUI 863619, 863636UNII 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
N468084048001followed by a unit qualifier and the quantityPackage 68084-0480-01. 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 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 aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). 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. (1) Oxybutynin chloride extended-release tablets are also indicated for the treatment of …
Excerpt only. Read the full label for complete information.
About NDC 68084-480
- What is NDC 68084-480?
- 68084-480 is the product NDC for Oxybutynin Chloride Extended Release, Oxybutynin chloride 5 mg/1 tablet, extended release, listed with the FDA by American Health Packaging. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxybutynin Chloride Extended Release (Oxybutynin Chloride).
- What is the active ingredient?
- Oxybutynin chloride.
- Who is the labeler?
- American Health Packaging, NDC labeler code 68084. 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 Extended Release?
- 24 other product NDCs are listed under this name. See all Oxybutynin Chloride Extended Release 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 Extended Release 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 Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6673 | 50090-6673-00 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6840 | 50090-6840-0050090-6840-01 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Rising Pharma Holdings, Inc. | 64980-209 | 64980-0209-0164980-0209-0364980-0209-05 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | Rising Pharma Holdings, Inc. | 64980-210 | 64980-0210-0164980-0210-05 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 15 mg/1 | Tablet, Extended releaseOral | Rising Pharma Holdings, Inc. | 64980-211 | 64980-0211-0164980-0211-05 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2121 | 71335-2121-0171335-2121-0271335-2121-03+1 more |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2330 | 71335-2330-0171335-2330-02 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-414 | 72789-0414-90 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 82804-095 | 82804-0095-30 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | AvKARE | 42291-633 | 42291-0633-0142291-0633-50 |
Other NDCs under ANDA 078503
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 | Chartwell RX, LLC | 62135-507 |
| oxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-508 |
| oxybutynin chloride | Oxybutynin chloride 15 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-509 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | AvKARE | 42291-633 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | AvKARE | 42291-634 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 15 mg/1 | Tablet, Extended releaseOral | AvKARE | 42291-635 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 43063-790 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-282 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-284 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-285 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 15 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-322 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | AvPAK | 50268-627 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | AvPAK | 50268-628 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 15 mg/1 | Tablet, Extended releaseOral | AvPAK | 50268-629 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Lannett Company, Inc. | 62175-270 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | Lannett Company, Inc. | 62175-271 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 15 mg/1 | Tablet, Extended releaseOral | Lannett Company, Inc. | 62175-272 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | American Health Packaging | 68084-610 |