Oxybutynin Chloride NDC 71610-394

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-394Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0394Add 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
71610-394-53	71610039453	60 TABLET in 1 BOTTLE, PLASTIC (71610-394-53)Marketed from Feb 5, 2020
71610-394-60	71610039460	90 TABLET in 1 BOTTLE, PLASTIC (71610-394-60)Marketed from Feb 5, 2020
71610-394-80	71610039480	180 TABLET in 1 BOTTLE, PLASTIC (71610-394-80)Marketed from Dec 30, 2022
71610-394-92	71610039492	270 TABLET in 1 BOTTLE, PLASTIC (71610-394-92)Marketed from Feb 5, 2020

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: Aphena Pharma Solutions - Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210125
Marketing start: Jan 1, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 71610-394_7dee4b0d-3071-4962-82b6-0b0ff220f91aSPL ID 7dee4b0d-3071-4962-82b6-0b0ff220f91aSPL set ID 1e1c1043-e4c5-4a06-9cc1-45d4397746f4RxCUI 863664UNII 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

N471610039453 followed by a unit qualifier and the quantity

Package 71610-0394-53. 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 Jan 4, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Oxybutynin chloride tablets are 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 210125

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

FDA NDC Directory listings under ANDA 210125
Product	Strength	Form · route	Labeler	Product NDC
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	TruPharma LLC	52817-260
Oxybutynin Chloride	Oxybutynin chloride 2.5 mg/1	TabletOral	TruPharma LLC	52817-261