Oxybutynin Chloride NDC 64380-190

NDC codes

FDA NDC Directory

Product NDC (as listed)64380-190Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64380-0190Add 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	Copy
64380-190-01	64380019001	100 TABLET in 1 BOTTLE (64380-190-01)Marketed from Apr 10, 2026

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 — 2.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Strides Pharma Science Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075079
Marketing start: Apr 10, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 64380-190_a34f3504-e5d9-426a-abee-6587854406a5SPL ID a34f3504-e5d9-426a-abee-6587854406a5SPL set ID 9ede5def-d185-4e40-9c10-8663ac654cafRxCUI 863664, 863758UNII L9F3D9RENQUPC 0364380162025, 0364380190011
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

N464380019001 followed by a unit qualifier and the quantity

Package 64380-0190-01. 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 Jul 1, 2026.

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 075079

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

FDA NDC Directory listings under ANDA 075079
Product	Strength	Form · route	Labeler	Product NDC
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-860
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	Strides Pharma Science Limited	64380-162