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Phenazopyridine Hydrochloride 99.5 mg Tablet, 3,360-count — NDC 63189-023-24 (Billing 63189-0023-24)

by AMOL PHARMACEUTICALS PRIVATE LIMITED · 140 BLISTER PACK in 1 CASE / 24 TABLET in 1 BLISTER PACK

This is a package of 3,360 tablets of Phenazopyridine Hydrochloride 99.5 mg Tablet from AMOL PHARMACEUTICALS PRIVATE LIMITED, marketed since Jan 2026 and currently FDA-listed. It is this product's only package size.

NDC 63189-0023-24
🏷️ FDA NDC (as labeled) 63189-023-24 billing pads the product segment with a zero
On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 63189-023-24 alone.

Record
FDA NDC Directory package listing · Drug for further processing
Code segments
63189 labeler · 023 product · 24 package
Package marketed since
Jan 1, 2026
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6318902324 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63189-023-24
Product NDC 63189-023
11-digit billing NDC 63189002324
SPL Set ID 17eabe75-7eed-4e11-8a53-cc44859858d1
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-01
Dosage form TABLET
Substance PHENAZOPYRIDINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 63189-023-24 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63189-0023-24. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It only helps with the pain — it doesn't kill the bacteria causing the infection. Think of it as taking the edge off while your antibiotic does the real work. If you have a UTI, yo...
  • Does phenazopyridine actually treat my UTI, or does it just help with the pain?
  • That's completely expected with phenazopyridine — it's one of the most common things people notice. The drug itself has an orange-red dye, and it passes into your urine, which is w...
  • Why is my urine turning orange or red? Should I be worried?
📖 Read our full Phenazopyridine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63189-0023-24 You're viewing this Main listing 140 BLISTER PACK in 1 CASE / 24 TABLET in 1 BLISTER PACK — — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
URO-PAIN Maximum Strength 99.5 mg 57237-0330-21 Rising 12 tablets $0.184 — Availability likely —
Good Neighbor Maximum Strength Urinary Pain Relief 99.5 mg 46122-0628-53 AmerisourceBergen 12 tablets $0.184 — Availability likely —
Foster and Thrive Maximum Strength Urinary Pain Relief 99.5 mg 70677-1230-01 Strategic 12 tablets $0.184 — Availability likely —
Leader Maximum Strength Urinary Pain Relief 99.5 mg 70000-0523-01 Cardinal 12 tablets $0.184 — Availability likely —
HealthMart Maximum Strength Urinary Pain Relief 99.5 mg 62011-0412-01 Strategic 12 tablets $0.186 — FDA listed —
Sunmark Maximum Strength Urinary Pain Relief 99.5 mg 70677-0078-01 Strategic 12 tablets $0.186 — FDA listed —
Maximum Strength Urinary Pain Relief 99.5 mg 30142-0756-24 KROGER 24 tablets — — FDA listed —
RIGHT REMEDIES Maximum Strength Urinary Pain Relief 99.5 mg 70692-0163-39 Strive 72 tablets — — FDA listed —
Cheeky Bonsai UTI Pain Relief 99.5 mg 81860-0113-24 IXXA, 24 tablets — — FDA listed —
Quality Choice Maximum Strength Urinary Pain Relief 99.5 mg 83324-0199-12 Chain 12 tablets — — FDA listed —
Preferred Maximum Strength Urinary Pain Relief 99.5 mg 10956-0210-12 Reese 12 tablets — — FDA listed —
Maximum Strength Urinary Pain Relief 99.5 mg 80513-0517-72 Advanced 72 tablets — — FDA listed —
Signature Care Maximum Strength Urinary Pain Relief 99.5 mg 21130-0792-24 Safeway 24 tablets — — FDA listed —
Phenazopyridine Hydrochloride 99.5 mg 50696-0003-01 GPT 25000 tablets — — FDA listed —
Discount Drugmart Maximum Strength Urinary Pain Relief 99.5 mg 53943-0336-12 Discount 12 tablets — — FDA listed —
Premier Value Maximum Strength Urinary Pain Relief 99.5 mg 68016-0129-12 Chain 12 tablets — — FDA listed —
Stix Maximum Strength Urinary Pain Relief 99.5 mg 80584-0113-24 Get 24 tablets — — FDA listed —
Phenazopyridine Hydrochloride 99.5 mg 63189-0019-20 Amol 130000 tablets — — FDA listed —
Meijer Maximum Strength Urinary Pain Relief 99.5 mg 41250-0342-12 Meijer 12 tablets — — FDA listed —
Dollar General Maximum Strength Urinary Pain Relief 99.5 mg 55910-0631-12 Dolgencorp, 12 tablets — — FDA listed —
Preferred Maximum Strength Urinary Pain Relief 99.5 mg 68788-7778-01 Preferred 12 tablets — — Discontinued —
Harris Teeter Maximum Strength Urinary Pain Relief 99.5 mg 69256-0767-12 Harris 12 tablets — — FDA listed —
Cystex Max UTI Pain Relief 99.5 mg 69693-0514-24 Clarion 24 tablets — — FDA listed —
CVS Maximum Strength Urinary Pain Relief 99.5 mg 69842-0713-12 CVS 12 tablets — — FDA listed —
Urinary Pain Relief 99.5 mg 73581-0919-12 YYBA 120 tablets — — FDA listed —
Phenazopyridine Hydrochloride 99.5 mgthis 63189-0023-24 AMOL 3360 tablets — — FDA listed —
Maximum Strength Urinary Pain Relief 99.5 mg 11673-0270-24 TARGET 24 tablets — — FDA listed —
Kroger Maximum Strength Urinary Pain Relief 99.5 mg 30142-0221-24 THE 24 tablets — — FDA listed —
GOOD REMEDIES Maximum Strength Urinary Pain Relief Caplet 99.5 mg 70692-0178-08 Strive 8 tablets — — FDA listed —
Family Dollar Maximum Strength Urinary Pain Relief 99.5 mg 55319-0211-12 Family 12 tablets — — FDA listed —
Uqora Maximum UTI Pain Relief 99.5 mg 73712-0114-12 Bonafide 12 tablets — — FDA listed —
Phenazopyridine Hydrochloride 99.5 mg 10267-0317-06 Contract 28 tablets — — FDA listed —
Phenazopyridine Hydrochloride 99.5 mg 63189-0011-24 Amol 3360 tablets — — FDA listed —
AZO Urinary Pain Relief Maximum Strength 99.5 mg 49973-0247-12 i-Health, 12 tablets — — FDA listed —
Care One Maximum Strength Urinary Pain Relief 99.5 mg 72476-0210-12 Retail 12 tablets — — FDA listed —
Phenazopyridine Hydrochloride 99.5 mg 62485-0050-24 TCB 24 tablets — — FDA listed —
Uti Pain Relief 99.5 mg 73436-2441-02 Cadence 12 tablets — — FDA listed —
Urinary Pain Relief 99.5 mg 73581-0909-72 YYBA 72 tablets — — Discontinued —
Rite Aid Maximum Strength Urinary Pain Relief 99.5 mg 11822-3111-02 Rite 12 tablets — — FDA listed —
Walmart Maximum Strength Urinary Pain Relief 99.5 mg 49035-0297-12 Walmart 12 tablets — — FDA listed —
Uristat Ultra 99.5 mg 63029-0105-12 Medtech 12 tablets — — FDA listed —
Monistat Maintain 99.5 mg 63736-0020-12 Insight 12 tablets — — FDA listed —
Quality Choice Maximum Strength Urinary Pain Relief 99.5 mg 63868-0297-12 Chain 12 tablets — — FDA listed —
Vexia Maximum Strength Urinary Pain Relief 99.5 mg 10956-0703-24 Reese 24 tablets — — FDA listed —
TopCare Maximum Strength Urinary Pain Relief 99.5 mg 36800-0510-12 TOPCO 12 tablets — — FDA listed —
Wallgreens Maximum Strength Urinary Pain Relief 99.5 mg 00363-8455-12 Walgreens 12 tablets — — FDA listed —
Gencare-Urinary Pain Relief Maximum Strength 99.5 mg 72090-0072-01 Pioneer 72 tablets — — FDA listed —
Nuvicare-Urinary Pain Relief Maximum Strength 99.5 mg 84324-0042-01 NUVICARE 24 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Phenazopyridine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAMOL PHARMACEUTICALS PRIVATE LIMITED
Labeler code63189
First marketedJan 2026
Product typeDrug For Further Processing
Portfolio10 products on file

More NDCs from AMOL PHARMACEUTICALS PRIVATE LIMITED labeler code 63189

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Phenazopyridine Hydrochloride — the ingredient across all brands.

Top reported reactions

Pain35
Dyspnoea33
Nausea32
Headache29
Fatigue27
Sulphaemoglobinaemia27
Urinary Tract Infection25

Age at onset

Adolescent2
Adult37
Elderly34

Reporter sex

325 reports

Serious outcomes

Hospitalization148
Life-threatening42
Death19
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 67 15
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: AMOL PHARMACEUTICALS PRIVATE LIMITED supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by AMOL PHARMACEUTICALS PRIVATE LIMITED. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
AMOL PHARMACEUTICALS PRIVATE LIMITED is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 63189-0022-24 · AMOL 63189-0024-20 · AMOL →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.