Phenazopyridine Hydrochloride NDC 70518-3975

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-3975Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-3975Add 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
70518-3975-0	70518397500	30 TABLET in 1 BLISTER PACK (70518-3975-0)Marketed from Jan 6, 2024
70518-3975-2	70518397502	9 TABLET in 1 BOTTLE, PLASTIC (70518-3975-2)Marketed from Nov 1, 2025
70518-3975-3	70518397503	6 TABLET in 1 BOTTLE, PLASTIC (70518-3975-3)Marketed from May 13, 2026
70518-3975-4	70518397504	50 POUCH in 1 BOX (70518-3975-4) / 1 TABLET in 1 POUCH (70518-3975-5)Marketed from May 14, 2026
70518-3975-6	70518397506	100 POUCH in 1 BOX (70518-3975-6) / 1 TABLET in 1 POUCH (70518-3975-5)Marketed from Jul 26, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Phenazopyridine Hydrochloride
Generic name (nonproprietary): phenazopyridine hydrochloride
Active ingredients: Phenazopyridine hydrochloride — 200 mg/1
Dosage form: Tablet
Route: Oral
Labeler: REMEDYREPACK INC.
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Jan 6, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 70518-3975_5796d1de-ee8d-ba66-e063-6294a90afca2SPL ID 5796d1de-ee8d-ba66-e063-6294a90afca2SPL set ID 6eb59b69-4ad0-47b1-bd3c-1d04d0852ec5RxCUI 1094104UNII 0EWG668W17

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

N470518397500 followed by a unit qualifier and the quantity

Package 70518-3975-00. 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 27, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Phenazopyridine Hydrochloride is indicated for the symptomatic relief of pain, burning, urgency frequency, and other discomforts arising from irritation of the mucosa of the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine Hydrochloride for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. The drug should be used for symptomatic relief of pain and not as a substitute for specific surgery or antimicrobial therapy. Phenazopyridine Hydrochloride is compatible with antimicrobial therapy and can help relieve pain and discomfort durin…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)