What is NDC 36800-510?

36800-510 is the product NDC for TopCare Maximum Strength Urinary Pain Relief, Phenazopyridine hydrochloride 99.5 mg/1 tablet, listed with the FDA by TOPCO ASSOCIATES LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

TopCare Maximum Strength Urinary Pain Relief (Phenazopyridine hydrochloride).

TOPCO ASSOCIATES LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for TopCare Maximum Strength Urinary Pain Relief?

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.

NDC 36800-510

NDC codes

FDA NDC Directory

Product NDC (as listed)36800-510Labeler and product segments. Claims need a package NDC.

Product NDC at billing width36800-0510Add 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
36800-510-12	3680005101236800051012	1 BLISTER PACK in 1 CARTON (36800-510-12) / 12 TABLET in 1 BLISTER PACKMarketed from Nov 14, 2019

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): TopCare Maximum Strength Urinary Pain Relief
Generic name (nonproprietary): phenazopyridine hydrochloride
Active ingredients: Phenazopyridine hydrochloride — 99.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: TOPCO ASSOCIATES LLCNDC labeler code 36800
Product type: Over-the-counter drug
Marketing category: Unapproved drug (other)
Marketing start: Jan 4, 2010
Listing expires: Dec 31, 2026
Identifiers: Product ID 36800-510_e5d6a5af-cd8f-4afa-9fc4-1a646002ce81SPL ID e5d6a5af-cd8f-4afa-9fc4-1a646002ce81SPL set ID 1662f712-6756-4dcd-bdfa-b4ed28c0d69aRxCUI 1094147UNII 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

N436800051012 followed by a unit qualifier and the quantity

Package 36800-0510-12. 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 Dec 18, 2024.

Indications (excerpt from the label)

Use Fast relief from urinary pain, burning, urgency and 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 36800-510

What is NDC 36800-510?: 36800-510 is the product NDC for TopCare Maximum Strength Urinary Pain Relief, Phenazopyridine hydrochloride 99.5 mg/1 tablet, listed with the FDA by TOPCO ASSOCIATES LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: TopCare Maximum Strength Urinary Pain Relief (Phenazopyridine hydrochloride).
What is the active ingredient?: Phenazopyridine hydrochloride.
Who is the labeler?: TOPCO ASSOCIATES LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for TopCare Maximum Strength Urinary Pain Relief?: 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.

TopCare Maximum Strength Urinary Pain Relief (Phenazopyridine hydrochloride) NDC 36800-510