NDC codes

FDA NDC Directory
Product NDC (as listed)52389-241Labeler and product segments. Claims need a package NDC.
Product NDC at billing width52389-0241Add 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 NDC11-digit (billing)PackageCopy
52389-241-2452389024124523890241241 BLISTER PACK in 1 CARTON (52389-241-24) / 24 TABLET, FILM COATED in 1 BLISTER PACK (52389-241-01)Marketed from Apr 29, 2008
52389-241-2852389024128523890241281 BLISTER PACK in 1 CARTON (52389-241-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK (52389-241-04)Marketed from Feb 20, 2014
52389-241-4852389024148523890241482 BLISTER PACK in 1 CARTON (52389-241-48) / 24 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 18, 2021

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)
Uricalm Maximum StrengthSuffix: Maximum Strength
Generic name (nonproprietary)
phenazopyridine hydochloride
Active ingredients
Phenazopyridine hydrochloride — 99.5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Kobayashi Healthcare International, Inc.NDC labeler code 52389
Product type
Over-the-counter drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Identifiers
Product ID 52389-241_316e93e7-3627-8e6a-e063-6294a90a1d28SPL ID 316e93e7-3627-8e6a-e063-6294a90a1d28SPL set ID 1d94b45c-ee0b-499d-aca2-e8cd8dd490d2RxCUI 1094147, 1094149UNII 0EWG668W17UPC 0072959415242

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

N452389024124 followed by a unit qualifier and the quantity

Package 52389-0241-24. 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 .

Indications (excerpt from the label)

Uses Prompt temporary relief of: pain during urination burning sensation of urgency increased frequency associated with urinary tract infections.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 52389-241

What is NDC 52389-241?
52389-241 is the product NDC for Uricalm Maximum Strength (phenazopyridine hydochloride), Phenazopyridine hydrochloride 99.5 mg/1 tablet, film coated, listed with the FDA by Kobayashi Healthcare International, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Uricalm Maximum Strength (Phenazopyridine Hydochloride).
What is the active ingredient?
Phenazopyridine hydrochloride.
Who is the labeler?
Kobayashi Healthcare International, Inc., NDC labeler code 52389. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Uricalm Maximum Strength?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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