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Rugby Phenazopyridine HCl Urinary Tract Analgesic PHENAZOPYRIDINE HYDROCHLORIDE 95 mg Tablet, 30-count — NDC 00536-1411-07 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Rugby Phenazopyridine HCl Urinary Tract Analgesic PHENAZOPYRIDINE HYDROCHLORIDE 95 mg Tablet, 30-count — NDC 0536-1411-07 (Billing 00536-1411-07)

by Rugby Laboratories · 1 BLISTER PACK in 1 CARTON / 30 TABLET in 1 BLISTER PACK

This is a package of 30 tablets of Rugby Phenazopyridine HCl Urinary Tract Analgesic PHENAZOPYRIDINE HYDROCHLORIDE 95 mg Tablet from Rugby Laboratories, marketed since Dec 2023 and currently FDA-listed; retail pharmacies pay about $0.1316 per tablet (NADAC). It is this product's only package size.

NDC 00536-1411-07
🏷️ FDA NDC (as labeled) 0536-1411-07 billing pads the labeler segment with a zero
OTC 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 0536-1411-07 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0536 labeler · 1411 product · 07 package
Package marketed since
Dec 7, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
30 EA per package
Barcode (UPC-A, from the NDC)
3 0536141107 7
Medicaid fills, this package
342 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0536-1411-07
Product NDC 0536-1411
11-digit billing NDC 00536141107
NCPDP billing unit EA — each (per item)
RxCUI 1094126
UNII 0EWG668W17
SPL Set ID 7519c0ac-586a-4aa5-a7fe-0e10cbc4bfc6
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-07
Route ORAL
Dosage form TABLET
Substance PHENAZOPYRIDINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 56300010100303
GCN Seq No 016828
GCN 42123
HICL code 004108
Ingredient (HICL) Phenazopyridine Hcl
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R5
Therapeutic class — intermediate (HIC2) Urinary Tract Anesthetic/Analgesic Agents
HIC3 code R5A
Therapeutic class — specific (HIC3) Urinary Tract Anesthetic/Analgesic Agnt (Azo-Dye)
AHFS code 84:08.00.00
AHFS class Antipruritics And Local Anesthetics
FDB label name PHENAZOPYRIDINE HCL 95 MG TAB
FDB brand name Phenazopyridine Hcl
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 016828
  • GCN: 42123
  • GPI-14 (Medi-Span): 56300010100303
  • HICL (First Databank): 004108
  • AHFS class code: 84:08.00.00
  • RxCUI (RxNorm): 1094126
Why two NDCs? The FDA registers this code as 0536-1411-07 — a 4-4-2 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 labeler segment → 00536-1411-07. 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.

RxNorm drug class

This medicine belongs to the Other urologicals class.

Drug family (ATC) Other urologicals
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name PHENAZOPYRIDINE HCL 95 MG TAB Ingredient Phenazopyridine Hcl
📗 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 eaPer package
Retail pharmacies payNADAC · weekly $0.132 $3.95 / 30 tablets
Medicaid paysCMS SDUD · 12 mo $3.09 $92.60 / 30 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.137 $0.126
▲ Up 4% over the last 10 months.
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
00536-1411-07 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 30 TABLET in 1 BLISTER PACK 2023-12-07 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Quality Choice Urinary Pain Relief 95 mg 63868-0117-30 Chain 30 tablets $0.118 — FDA listed save 10%
HealthMart Urinary Pain Relief 95 mg 62011-0325-01 Strategic 30 tablets $0.120 — FDA listed save 9%
Rugby Phenazopyridine HCl Urinary Tract Analgesic 95 mgthis 00536-1411-07 Rugby 30 tablets $0.132 — Availability likely —
Good Neighbor Pharmacy Urinary Pain Relief 95 mg 46122-0337-65 AmerisourceBergen 30 tablets $0.132 — Availability likely —
Uro-Pain 95 mg 57237-0331-03 Rising 30 tablets $0.132 — Availability likely —
Leader Urinary Pain Relief 95 mg 70000-0243-01 Cardinal 30 tablets $0.132 — Availability likely —
Foster and Thrive Neighbor Pharmacy Urinary Pain Relief 95 mg 70677-1229-01 Strategic 30 tablets $0.132 — Availability likely —
Sunmark Urinary Pain Relief 95 mg 49348-0076-44 Strategic 30 tablets $0.132 — Availability likely +0%
Walgreens Urinary Pain Relief 95 mg 00363-7775-30 Walgreens 30 tablets — — FDA listed —
CVS Health Urinary Pain Relief 95 mg 10956-0001-30 Reese 30 tablets — — FDA listed —
Preferred Urinary Pain Relief 95 mg 10956-0551-30 Reese 30 tablets — — FDA listed —
Rite Aid Urinary Pain Relief 95 mg 11822-8855-06 Rite 30 tablets — — FDA listed —
Kroger Urinary Pain Relief 95 mg 30142-0564-30 THE 30 tablets — — FDA listed —
TopCare Urinary Pain Relief 95 mg 36800-0040-30 TOPCO 30 tablets — — FDA listed —
Skopko Urinary Pain Relief 95 mg 37012-0098-01 Skopko 32 tablets — — FDA listed —
Azo 95 mg 49973-0301-31 i-Health, 30 tablets — — FDA listed —
Phenazopyridine Hydrochloride 95 mg 68071-2273-03 NuCare 30 tablets — — FDA listed —
Good Neighbor Pharmacy Urinary Pain Relief 95 mg 71205-0584-30 Proficient 30 tablets — — FDA listed —
Quality Choice Urinary Pain Relief 95 mg 83324-0201-30 Chain 30 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

🏛️
2023
On the market since
Dec 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
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.

What it looks like

Color red
ShapeRound
ImprintP95
Size7 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII J2B2A4N98G
    Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII AG9B65PV6B
    A starch derivative made from corn that helps tablets and capsules break apart quickly when swallowed. It acts as a disintegrant, allowing the medicine to dissolve and be absorbed in your stomach and intestines.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

12 inactive ingredients listed in the exact product block matched to this NDC.

The official label also stateslactose, corn starch, croscarmellose sodium, microcrystalline cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyvinylpyrrolidone, sodium starch glycolate,  pregelatinized starch, silicon dioxide, talc, and triacetin.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerRugby Laboratories
Labeler code00536
First marketedDec 2023
Product typeHuman Otc Drug
Portfolio149 products on file

More NDCs from Rugby Laboratories labeler code 00536

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.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information
🎯 Indications and Usage 13 words ▾

Uses fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.

⏱️ Dosage and Administration 50 words ▾

Directions ■ Adults and children 12 years and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed ■ Children under 12 years: consult a doctor ■ Do not use for more than 2 days (12 tablets) without consulting a doctor

⚠️ Warnings 21 words ▾

Warning Do not exceed recommended dosage Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician

🧪 Active Ingredient 6 words ▾

Active Ingredient Phenazopyridine Hydrochloride 95 mg

🧪 Inactive Ingredients 28 words ▾

Inactive Ingredients lactose, corn starch, croscarmellose sodium, microcrystalline cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyvinylpyrrolidone, sodium starch glycolate, pregelatinized starch, silicon dioxide, talc, and triacetin. image of carton

🎯 Purpose 3 words ▾

Purpose Urinary Analgesic

📄 Ask a Doctor Before Use If 24 words ▾

Ask Doctor before use if you have ■ kidney disease ■ allergies to foods, preservatives or dyes ■ had a hypersensitive reaction to Phenazopyridine

📄 When Using This Product 48 words ▾

When using this product ■ When using this product stomach upset may occur, taking this product with or after meals may reduce stomach upset ■ your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items.

📄 Stop Use and Ask a Doctor If 65 words ▾

Stop use and ask a doctor if ■ your symptoms last for more than 2 days ■ you suspect you are having an adverse reaction to the medication Long-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.

🤰 If Pregnant or Breast-Feeding 11 words ▾

If pregnant or breast feeding ask a health professional before use.

📄 Keep Out of Reach of Children 23 words ▾

Keep out of the reach of children in case of an overdose,get medical help or contact a Poison Control Center right away 1-800-222-1222.

📄 Other Information 39 words ▾

Other Information ■ this product may stain contact lenses ■ this product can interfere with laboratory tests including urine, glucose (sugar), and ketones test ■ Store at room temperature 15-30C (59-86°F) in a dry place and protect from light

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
342
Units reimbursed last 4 qtrs
6K
Gross reimbursed last 4 qtrs
$18.6K
Avg / prescription
$54.28
Avg / unit
$3.0865
Latest quarter Q1 2026
87Rx
Medicaid pays / ea
$3.0865
gross reimbursed
vs
NADAC / ea
$0.1316
acquisition cost
=
Spread
+$2.9549
+2245% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 342 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 236 units · 4.1 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 2,670 units · 22.7 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 1,500 units · 75.8 per 100k residents NE Missouri: no data reported MO Kentucky: 1,314 units · 29.0 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 199 units · 3.2 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 96 units · 1.3 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.375.8
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Nebraska 75.8 /100k
2 Kentucky 29.0 /100k
3 Ohio 22.7 /100k
4 Minnesota 4.1 /100k
5 Maryland 3.2 /100k
6 Arizona 1.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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
Male · 22%
Female · 78%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 26 0
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

Over-the-counter (OTC) product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
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) ✓ Available
“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 "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
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 Rugby Laboratories. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Rugby Laboratories 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.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.
← 00536-1408-94 · Rugby 00536-1412-20 · RUGBY →
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.