Urelle NDC 0037-6321

NDC codes

FDA NDC Directory

Product NDC (as listed)0037-6321Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00037-6321Add 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
0037-6321-90	00037632190	90 TABLET in 1 BOTTLE (0037-6321-90)Marketed from Jan 12, 2015

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): Urelle
Generic name (nonproprietary): hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate
Active ingredients: Hyoscyamine sulfate — .12 mg/1Methenamine — 81 mg/1Methylene blue — 10.8 mg/1Phenyl salicylate — 32.4 mg/1Sodium phosphate, Monobasic, Monohydrate — 40.8 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Viatris Specialty LLC
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Jan 12, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Oxidation-Reduction Activity (Mechanism)
Identifiers: Product ID 0037-6321_a8f8f4f1-ad2a-40af-9089-764a459fb8fdSPL ID a8f8f4f1-ad2a-40af-9089-764a459fb8fdSPL set ID 1d80a11c-6f86-403b-85d4-32ec1924dbe9RxCUI 1048336, 1048340UNII F2R8V82B84, J50OIX95QV, T42P99266K, 28A37T47QO, 593YOG76RN
Pharmacologic class: Oxidation-Reduction Agent

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

N400037632190 followed by a unit qualifier and the quantity

Package 00037-6321-90. 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 Jan 13, 2015.

Indications (excerpt from the label)

INDICATIONS and USAGE: Urelle ® is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)