Oxybutynin Chloride NDC 69315-182

NDC codes

FDA NDC Directory

Product NDC (as listed)69315-182Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69315-0182Add 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 NDC	11-digit (billing)	Package
69315-182-01	69315018201	100 TABLET in 1 BOTTLE (69315-182-01)Marketed from Nov 1, 2019
69315-182-05	69315018205	500 TABLET in 1 BOTTLE (69315-182-05)Marketed from Nov 1, 2019
69315-182-10	69315018210	1000 TABLET in 1 BOTTLE (69315-182-10)Marketed from Nov 1, 2019

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 — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Leading Pharma, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212798
Marketing start: Nov 1, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 69315-182_da4b3e8b-09d1-4ef3-a24a-ef078f13bd92SPL ID da4b3e8b-09d1-4ef3-a24a-ef078f13bd92SPL set ID b73b8338-8045-448f-87a6-3d289227d00eRxCUI 863664UNII L9F3D9RENQUPC 0369315182017, 0369315182109, 0369315182055
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

N469315018201 followed by a unit qualifier and the quantity

Package 69315-0182-01. 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 Feb 14, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Oxybutynin chloride is indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212798

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

FDA NDC Directory listings under ANDA 212798
Product	Strength	Form · route	Labeler	Product NDC
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8492
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	A-S Medication Solutions	50090-6199
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	Redpharm Drug	67296-2045