Prescription drug · ANDA
oxybutynin chloride NDC 16729-318
Oxybutynin chloride 10 mg/1 · Tablet, Extended release · Oral · Accord Healthcare, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-318-01 | 1672903180116729031801 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-318-01)Marketed from Dec 20, 2016 | |
| 16729-318-16 | 1672903181616729031816 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-318-16)Marketed from Apr 17, 2017 |
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
- Generic name (nonproprietary)
- oxybutynin chloride
- Active ingredients
- Oxybutynin chloride — 10 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Accord Healthcare, Inc.NDC labeler code 16729
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207138
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 16729-318_461437aa-cf86-2475-e063-6294a90afe5bSPL ID 461437aa-cf86-2475-e063-6294a90afe5bSPL set ID 61496a1e-17bf-4f45-a20c-5bb98fe545eeRxCUI 863619, 863628, 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
N416729031801followed by a unit qualifier and the quantityPackage 16729-0318-01. 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.
About NDC 16729-318
- What is NDC 16729-318?
- 16729-318 is the product NDC for oxybutynin chloride, Oxybutynin chloride 10 mg/1 tablet, extended release, listed with the FDA by Accord Healthcare, Inc.. It has 2 package NDCs, 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?
- Accord Healthcare, Inc., NDC labeler code 16729. 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 15 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1600 | 67046-1600-03 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1599 | 67046-1599-03 |
Other NDCs under ANDA 207138
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 | Accord Healthcare, Inc. | 16729-317 |
| oxybutynin chloride | Oxybutynin chloride 15 mg/1 | Tablet, Extended releaseOral | Accord Healthcare, Inc. | 16729-319 |
| oxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-4307 |
| oxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-5822 |
| oxybutynin chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-9689 |
| oxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-667 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | direct rx | 72189-131 |
| Oxybutynin Chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | DIRECT RX | 72189-132 |
| oxybutynin chloride | Oxybutynin chloride 10 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-049 |