Oxybutynin Chloride NDC 54838-510

NDC codes

FDA NDC Directory

Product NDC (as listed)54838-510Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54838-0510Add 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
54838-510-80	54838051080	473 mL in 1 BOTTLE, PLASTIC (54838-510-80)Marketed from Mar 29, 1996

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/5mL
Dosage form: Syrup
Route: Oral
Labeler: Lannett Company, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074520
Marketing start: Mar 29, 1996
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 54838-510_693f3eb4-b7f1-420a-b813-ecd8e326882dSPL ID 693f3eb4-b7f1-420a-b813-ecd8e326882dSPL set ID 615f3d95-197c-4fec-b81f-c26449c93c3bRxCUI 863599UNII L9F3D9RENQUPC 0354838510805
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

N454838051080 followed by a unit qualifier and the quantity

Package 54838-0510-80. 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 21, 2020.

Indications (excerpt from the label)

INDICATIONS AND USAGE Oxybutynin Chloride Syrup 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 074520

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

FDA NDC Directory listings under ANDA 074520
Product	Strength	Form · route	Labeler	Product NDC
Oxybutynin Chloride	Oxybutynin chloride 5 mg/5mL	SyrupOral	ATLANTIC BIOLOGICALS CORP.	17856-0149