Prescription drug · ANDA
Oxybutynin Chloride Extended Release NDC 64980-210
oxybutynin chloride · Oxybutynin chloride 10 mg/1 · Tablet, Extended release · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-210-01 | 64980021001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-210-01)Marketed from Sep 27, 2016 | |
| 64980-210-05 | 64980021005 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-210-05)Marketed from Mar 29, 2022 |
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 — 10 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206121
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 64980-210_6393f9a1-b51b-4baa-81f3-bb02d5e7dbc3SPL ID 6393f9a1-b51b-4baa-81f3-bb02d5e7dbc3SPL set ID ab431781-3183-4638-b656-f40a61f07940RxCUI 863619, 863628, 863636UNII L9F3D9RENQUPC 0364980211017, 0364980210010, 0364980209014
- 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
N464980021001followed by a unit qualifier and the quantityPackage 64980-0210-01. 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 o…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206121
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 Extended Releaseoxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2330 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 82804-095 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6673 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2121 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6840 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Rising Pharma Holdings, Inc. | 64980-209 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-414 |
| Oxybutynin Chloride Extended Releaseoxybutynin chloride | Oxybutynin chloride 15 mg/1 | Tablet, Extended releaseOral | Rising Pharma Holdings, Inc. | 64980-211 |