What is NDC 0574-0115?

0574-0115 is the product NDC for Flavoxate Hydrochloride, Flavoxate hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Padagis US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Padagis US LLC, NDC labeler code 0574. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Flavoxate Hydrochloride?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Flavoxate Hydrochloride NDC 0574-0115

NDC codes

FDA NDC Directory

Product NDC (as listed)0574-0115Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00574-0115Add 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
0574-0115-01	0057401150100574011501	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0574-0115-01)Marketed from Dec 22, 2004

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Flavoxate Hydrochloride
Generic name (nonproprietary): flavoxate hydrochloride
Active ingredients: Flavoxate hydrochloride — 100 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Padagis US LLCNDC labeler code 0574
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076831
Marketing start: Dec 22, 2004
Marketing end: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 0574-0115_ff1c0ee9-75d2-478a-9152-0753be81ff11SPL ID ff1c0ee9-75d2-478a-9152-0753be81ff11SPL set ID a9c44c4b-5b3c-45bf-9bc9-ce858e3d06c5RxCUI 1095229UNII 9C05J6089WUPC 0305740115015
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

N400574011501 followed by a unit qualifier and the quantity

Package 00574-0115-01. 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 May 31, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Flavoxate HCl tablets are indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Flavoxate HCl tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0574-0115

What is NDC 0574-0115?: 0574-0115 is the product NDC for Flavoxate Hydrochloride, Flavoxate hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Padagis US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Flavoxate Hydrochloride.
What is the active ingredient?: Flavoxate hydrochloride.
Who is the labeler?: Padagis US LLC, NDC labeler code 0574. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Flavoxate Hydrochloride?: 2 other product NDCs are listed under this name. See all Flavoxate Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Flavoxate Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Flavoxate Hydrochloride	Flavoxate hydrochloride 100 mg/1	TabletOral	PuraCap Laboratories LLC dba Blu Pharmaceuticals	24658-720	24658-0720-01
Flavoxate Hydrochloride	Flavoxate hydrochloride 100 mg/1	TabletOral	Epic Pharma, LLC	42806-058	42806-0058-0142806-0058-10