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Me NaPhos MB Hyo 1 Urinary Antiseptic Antispasmodic 81.6 mg; 40.8 mg; 10.8 mg; .12 mg Tablet, 100-count — NDC 58657-0454-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Me NaPhos MB Hyo 1 Urinary Antiseptic Antispasmodic 81.6 mg; 40.8 mg; 10.8 mg; .12 mg Tablet, 100-count — NDC 58657-454-01 (Billing 58657-0454-01)

by Method Pharmaceuticals · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Me NaPhos MB Hyo 1 Urinary Antiseptic Antispasmodic 81.6 mg; 40.8 mg; 10.8 mg; .12 mg Tablet from Method Pharmaceuticals, marketed since Dec 2015 and currently FDA-listed; retail pharmacies pay about $3.98 per tablet (NADAC). It is this product's only package size.

NDC 58657-0454-01
🏷️ FDA NDC (as labeled) 58657-454-01 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58657-454-01
Product NDC 58657-454
11-digit billing NDC 58657045401
NCPDP billing unit EA — each (per item)
RxCUI 1050325
UNII J50OIX95QV, 593YOG76RN, 8NAP7826UB, OB570Z127K
UPC 0358657454012
SPL Set ID 2ae628e7-3b33-6a9a-e054-00144ff8d46c
Established class (EPC) Oxidation-Reduction Agent
Mechanism of action Oxidation-Reduction Activity
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-12-01
Route ORAL
Dosage form TABLET
Substance METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; METHYLENE BLUE ANHYDROUS; HYOSCYAMINE SULFATE ANHYDROUS

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

GPI-14 16992004200325
GPI class ME/NaPhos/MB/Hyo1
GCN Seq No 066593
GCN 28868
HICL code 037115
Ingredient (HICL) Methenam/Sod Phos/Mblue/Hyoscy
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W2
Therapeutic class — intermediate (HIC2) Antibacterials
HIC3 code W2G
Therapeutic class — specific (HIC3) Antibiotic, Antibacterial, Misc.
AHFS code 08:36.00.00
AHFS class Urinary Anti-Infectives
FDB label name ME-NAPHOS-MB-HYO 1 TABLET
FDB brand name Me-Naphos-Mb-Hyo 1
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 066593
  • GCN: 28868
  • GPI-14 (Medi-Span): 16992004200325
  • HICL (First Databank): 037115
  • AHFS class code: 08:36.00.00
  • RxCUI (RxNorm): 1050325
Why two NDCs? The FDA registers this code as 58657-454-01 — 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 → 58657-0454-01. 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 Belladonna alkaloids, tertiary amines class.

Drug family (ATC) Belladonna alkaloids, tertiary amines
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 ME-NAPHOS-MB-HYO 1 TABLET Ingredient Methenam/Sod Phos/Mblue/Hyoscy
🧪 What is this product?

This is an oral tablet containing four active ingredients: hyoscyamine sulfate (an antispasmodic agent typically used to reduce muscle spasms), methenamine and methylene blue anhydrous (urinary antiseptics commonly used to address urinary tract symptoms), and sodium phosphate monobasic monohydrate (a phosphate salt often included in urinary formulations). The combination is intended to function as a urinary antiseptic and antispasmodic. This product is marketed without an approved FDA application.

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 $3.976 $397.61 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $2.62 $262.07 / 100 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 2021 Oct 2022 Mar 2026 Sep 2026 $4.301 $2.569
▲ Up 41% over the last 19 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
58657-0454-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2015-12-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Urogesic Blue 81.6 mg/1; 40.8 mg/1; 10.8 mg/1; .12 mg 00485-0151-01 EDWARDS 100 tablets $3.976 — Availability likely —
Me NaPhos MB Hyo 1 81.6 mg/1; 40.8 mg/1; 10.8 mg/1; .12 mgthis 58657-0454-01 Method 100 tablets $3.976 — Availability likely —
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

🏛️
2015
On the market since
Dec 2015
📍
2026
Currently FDA-listed
11 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 blue
ShapeOval
ImprintM455
Size1 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.

💡 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 H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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.

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

The official label also statesMicrocrystalline Cellulose, Mannitol, Croscarmellose Sodium, Magnesium Stearate, FD&C Blue #1 HYOSCYAMINE SULFATE is an alkaloid of belladonna. Exists as a white crystalline powder. Affected by light It is very soluble in water; freely soluble in alcohol; practically insoluble in ether. METHENAMINE exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water; soluble in alcohol and in chloroform. METHYLENE BLUE exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. MONOBASIC SODIUM PHOSPHAT E exists as a white crystalline powder. Its solutions are acidic to litmus. It is freely soluble in water and practically insoluble in alcohol. This product is not an Orange Book (OB) rated product, therefore all prescriptions using this product shall be pursuant to state statutes as applicable. There are no claims of bioequivalence or therapeutic equivalence.

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

LabelerMethod Pharmaceuticals
Labeler code58657
First marketedDec 2015
Product typeHuman Prescription Drug
Portfolio11 products on file
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 prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 🧪 Inactive Ingredients 📋 Description 📄 Other Information ⚠️ Precautions 🔒 Drug Abuse and Dependence 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 47 words ▾

INDICATION AND USAGE ME/NaPhos/MB/Hyo 1 Tablets is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as hypermotility which accompany lower urinary tract infections and as antispasmodic. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

⏱️ Dosage and Administration 36 words ▾

DOSAGE AND ADMINISTRATION Adults One tablet orally 4 times per day followed by liberal fluid intake. Older Children Dosage must be individualized by physician. Not recommended for use in children up to 6 years of age.

⚠️ Warnings 18 words ▾

WARNINGS Do not exceed recommended dosage. If rapid pulse, dizziness, or blurring of vision occurs discontinue use immediately.

🤒 Adverse Reactions 35 words ▾

ADVERSE REACTIONS Cardiovascula r – rapid pulse, flushing Central Nervous System – blurred vision, dizziness Respiratory – shortness of breath or troubled breathing Genitourinary – difficulty micturition, acute urinary retention Gastrointestinal – dry mouth, nausea/vomiting

🔄 Drug Interactions 196 words ▾

Drug Interactions because of this product's effect on gastrointestinal motility and gastric emptying, it may decrease the absorption of other oral medications during concurrent use such as: urinary alkalizers; thiazide diuretics (may cause the urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde); antimuscarinics (concurrent use may intensify antimuscarinic effects of hyoscyamine because of secondary antimuscarinic activities of these medications); antacids/antidiarrheals (may reduce absorption of hyoscyamine, concurrent use with antacids may cause urine to become alkaline reducing effectiveness of methenamine by inhibiting its conversion to formaldehyde) doses of these medications should be spaced 1 hour apart from doses of hyoscyamine; antimyasthenics (concurrent use with hyoscyamine may further reduce intestinal motility); ketoconazole (patients should be advised to take this combination at least 2 hours after ketoconazole); monoamine oxidase (MAO) Inhibitors (concurrent use may intensify antimuscarinic side effects, opioid (narcotic) analgesics may result in increased risk of severe constipation); sulfonamides (these drugs may precipitate with formaldehyde in the urine, increasing the danger of crystalluria).

Patients should be advised that the urine may become blue to blue green and the feces may be discolored as a result of the excretion of methylene blue.

🧒 Pediatric Use 16 words ▾

Pediatric infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids.

🧓 Geriatric Use 22 words ▾

Geriatric use with caution in elderly patients as they may respond to usual doses of hyoscyamine with excitement, agitation, drowsiness, or confusion.

🆘 Overdosage 64 words ▾

OVERDOSAGE Emesis or gastric lavage. Slow intravenous administration of physostigmine in doses of 1 mg to 4 mg (0.5 mg to 1 mg in children), repeated as needed in one to two hours to reverse severe antimuscarinic symptoms. Administration of small doses of diazepam to control excitement and seizures. Artificial respiration with oxygen if needed for respiratory depression. Adequate hydration. Symptomatic treatment as necessary.

🧬 Clinical Pharmacology 206 words ▾

CLINICAL PHARMACOLOGY HYOSCYAMINE is a parasympatholytic which relaxes smooth muscles and thus produces an antispasmodic effect. It is well absorbed from the gastrointestinal tract and is rapidly distributed throughout body tissues. Most is excreted in the urine within 12 hours, 13% to 50% being unchanged.

Its biotransformation is hepatic. Its protein binding is moderate. METHENAMINE degrades in an acidic urine environment releasing formaldehyde which provides bactericidal or bacteriostatic action.

It is well absorbed from the gastrointestinal tract. 70% to 90% reaches the urine unchanged at which point it is hydrolyzed if the urine is acidic. Within 24 hours it is almost completely (90%) excreted; of this amount at pH 5, approximately 20% is formaldehyde.

Protein binding: some formaldehyde is bound to substances in the urine and surrounding tissues. Methenamine is freely distributed to body tissue and fluids but is not clinically significant as it does not hydrolyze at pH greater than 6.8. METHYLENE BLU E possesses weak antiseptic properties.

It is well absorbed in the gastrointestinal tract and is rapidly reduced to leukomethylene blue which is stabilized in some combination form in the urine. 75% is excreted unchanged. MONOBASIC SODIUM PHOSPHATE helps to maintain an acid pH in the urine necessary for the degradation of methenamine.

📦 How Supplied / Storage and Handling 35 words ▾

HOW SUPPLIED ME/NaPhos/MB/Hyo 1 Tablets are light blue to blue, oval, biconvex tablets debossed with "M455" with scoreline on one side and plain on the other side. Supplied in bottles of 100 tablets (NDC 58657-454-01).

🧪 Inactive Ingredients 148 words ▾

Inactive Ingredients include: Microcrystalline Cellulose, Mannitol, Croscarmellose Sodium, Magnesium Stearate, FD&C Blue #1 HYOSCYAMINE SULFATE is an alkaloid of belladonna. Exists as a white crystalline powder. Affected by light It is very soluble in water; freely soluble in alcohol; practically insoluble in ether.

METHENAMINE exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water; soluble in alcohol and in chloroform.

METHYLENE BLUE exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. MONOBASIC SODIUM PHOSPHAT E exists as a white crystalline powder.

Its solutions are acidic to litmus. It is freely soluble in water and practically insoluble in alcohol. This product is not an Orange Book (OB) rated product, therefore all prescriptions using this product shall be pursuant to state statutes as applicable.

There are no claims of bioequivalence or therapeutic equivalence.

📋 Description 26 words ▾

Description Each tablet contains: Methenamine, USP ................................. 81.6 mg Monobasic Sodium Phosphate, USP ......... 40.8 mg Methylene Blue ....................................... 10.8 mg Hyoscyamine Sulfate ............................... 0.12 mg

📄 Other Information 43 words ▾

CAUTION RX ONLY STORAGE Store at 25° C (77° F); excursions permitted to 15° C to 30° C (59° F to 86° F) [See USP Controlled Room Temperature]. Keep container tightly closed. Distributed By: Method Pharmaceuticals, LLC Arlington, TX 76006 Rev. Date: 01/2016

⚠️ Precautions 55 words ▾

PRECAUTIONS (Pregnancy Category C) hyoscyamine and methenamine cross the placenta. Studies have not been done in animals or humans. It is not known whether ME/NaPhos/MB/Hyo 1 Tablets cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ME/NaPhos/MB/Hyo 1 Tablets should be given to a pregnant woman only if clearly needed.

🔒 Drug Abuse and Dependence 33 words ▾

DRUG ABUSE AND DEPENDENCE A dependence on the use of ME/NaPhos/MB/Hyo 1 Tablets has not been reported and due to the nature of its ingredients, abuse of ME/NaPhos/MB/Hyo 1 Tablets is not expected.

📄 Package Label / Principal Display Panel 17 words ▾

Distributed by: Method Pharmaceuticals, LLC Arlington, TX 76006 Rev. Date: 01/2016 Pinciple Display Panel Booklet lab booklet

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
943
Units reimbursed last 4 qtrs
41.8K
Gross reimbursed last 4 qtrs
$109.4K
Avg / prescription
$116.03
Avg / unit
$2.6207
Latest quarter Q1 2026
229Rx
Medicaid pays / ea
$2.6207
gross reimbursed
vs
NADAC / ea
$3.9761
acquisition cost
=
Spread
−$1.3554
-34% 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 ⓘ
45% FFS 55% MCO
Fee-for-service · 424 Rx Managed care · 519 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: no data reported 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: no data reported OH Pennsylvania: no data reported PA New Jersey: 3,860 units · 41.6 per 100k residents NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: 4,890 units · 83.2 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 4,898 units · 108 per 100k residents KY West Virginia: 900 units · 50.8 per 100k residents WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 663 units · 22.6 per 100k residents KS Arkansas: no data reported AR Tennessee: 2,991 units · 42.0 per 100k residents TN North Carolina: 3,386 units · 31.3 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 10,894 units · 238 per 100k residents LA Mississippi: 2,293 units · 78.0 per 100k residents MS Alabama: 6,975 units · 137 per 100k residents 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
22.6238
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 Louisiana 238 /100k
2 Alabama 137 /100k
3 Kentucky 108 /100k
4 Colorado 83.2 /100k
5 Mississippi 78.0 /100k
6 West Virginia 50.8 /100k
7 Tennessee 42.0 /100k
8 New Jersey 41.6 /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.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Me-Naphos-Mb-Hyo 1 — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Me-Naphos-Mb-Hyo 1. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$19.3K
Claims incl. refills
221
Beneficiaries
162
Spend / beneficiary
$119.23
Spend / claim
$87.40
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription 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 Method Pharmaceuticals. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Method Pharmaceuticals 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 58657-0419-01 · Method 58657-0456-01 · Method →
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.