Oxybutynin Chloride Extended Release NDC 43353-282

Product information

Brand name (proprietary)

Oxybutynin Chloride Extended ReleaseSuffix: Extended Release

Generic name (nonproprietary)

oxybutynin chloride

Active ingredients

Oxybutynin chloride — 5 mg/1

Dosage form

Tablet, Extended release

Route

Oral

Labeler

Aphena Pharma Solutions - Tennessee, LLC

Product type

Prescription drug

Marketing category

ANDA — Abbreviated New Drug Application (generic)Application ANDA 078503

Marketing start

Mar 9, 2016

Listing expires

Dec 31, 2026

Other FDA classes

Cholinergic Muscarinic Antagonists (Mechanism)

Identifiers

Product ID 43353-282_a9056bad-e15c-4be4-a63c-f51362e2f025SPL ID a9056bad-e15c-4be4-a63c-f51362e2f025SPL set ID 02ff3be7-fc5c-4b91-8c67-ecdf6e19c42aRxCUI 863619, 863628, 863636UNII 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

N443353028230 followed by a unit qualifier and the quantity Copy

Package 43353-0282-30. 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

Other NDCs under ANDA 078503

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