NDC codes

FDA NDC Directory
Product NDC (as listed)43063-790Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0790Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
43063-790-904306307909090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-790-90)Marketed from Sep 21, 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 Extended ReleaseSuffix: Extended Release
Generic name (nonproprietary)
oxybutynin chloride
Active ingredients
Oxybutynin chloride — 10 mg/1
Dosage form
Tablet, Extended release
Route
Oral
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 43063-790_419e3f00-a475-03d5-e063-6394a90a5f89SPL ID 419e3f00-a475-03d5-e063-6394a90a5f89SPL set ID b5653b7e-1e3b-4da3-b3a2-33318f448c67RxCUI 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

N443063079090 followed by a unit qualifier and the quantity

Package 43063-0790-90. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078503

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078503
ProductStrengthForm · routeLabelerProduct NDC
oxybutynin chlorideOxybutynin chloride 15 mg/1Tablet, Extended releaseOralChartwell RX, LLC62135-509
oxybutynin chlorideOxybutynin chloride 5 mg/1Tablet, Extended releaseOralChartwell RX, LLC62135-507
oxybutynin chlorideOxybutynin chloride 10 mg/1Tablet, Extended releaseOralChartwell RX, LLC62135-508
Oxybutynin Chloride Extended Releaseoxybutynin chlorideOxybutynin chloride 5 mg/1Tablet, Extended releaseOralAmerican Health Packaging68084-480
Oxybutynin Chloride Extended Releaseoxybutynin chlorideOxybutynin chloride 15 mg/1Tablet, Extended releaseOralAvPAK50268-629
Oxybutynin Chloride Extended Releaseoxybutynin chlorideOxybutynin chloride 5 mg/1Tablet, Extended releaseOralAvPAK50268-627
Oxybutynin Chloride Extended Releaseoxybutynin chlorideOxybutynin chloride 10 mg/1Tablet, Extended releaseOralAvPAK50268-628
Oxybutynin Chloride Extended Releaseoxybutynin chlorideOxybutynin chloride 5 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC43353-282
Oxybutynin Chloride Extended Releaseoxybutynin chlorideOxybutynin chloride 10 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC43353-284
Oxybutynin Chloride Extended Releaseoxybutynin chlorideOxybutynin chloride 10 mg/1Tablet, Extended releaseOralAmerican Health Packaging68084-610
Oxybutynin Chloride Extended Releaseoxybutynin chlorideOxybutynin chloride 5 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC43353-285
Oxybutynin Chloride Extended Releaseoxybutynin chlorideOxybutynin chloride 15 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC43353-322
Oxybutynin Chloride Extended Releaseoxybutynin chlorideOxybutynin chloride 5 mg/1Tablet, Extended releaseOralAvKARE42291-633
Oxybutynin Chloride Extended Releaseoxybutynin chlorideOxybutynin chloride 10 mg/1Tablet, Extended releaseOralAvKARE42291-634
Oxybutynin Chloride Extended Releaseoxybutynin chlorideOxybutynin chloride 15 mg/1Tablet, Extended releaseOralAvKARE42291-635
Oxybutynin Chloride Extended Releaseoxybutynin chlorideOxybutynin chloride 5 mg/1Tablet, Extended releaseOralLannett Company, Inc.62175-270
Oxybutynin Chloride Extended Releaseoxybutynin chlorideOxybutynin chloride 10 mg/1Tablet, Extended releaseOralLannett Company, Inc.62175-271
Oxybutynin Chloride Extended Releaseoxybutynin chlorideOxybutynin chloride 15 mg/1Tablet, Extended releaseOralLannett Company, Inc.62175-272

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