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Multi-Vitamin Drops with Fluoride and Iron VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, Ferrous sulfate and SODIUM 1500 [iU]/mL; 35 mg/mL; 400 [iU]/mL; 5 [iU]/mL; .5 mg/mL; 5'-PHOSPHATE SODIUM .6 mg/mL; 8 mg/mL; .4 m Liquid — NDC 58657-0327-50 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Multi-Vitamin Drops with Fluoride and Iron VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, Ferrous sulfate and SODIUM 1500 [iU]/mL; 35 mg/mL; 400 [iU]/mL; 5 [iU]/mL; .5 mg/mL; 5'-PHOSPHATE SODIUM .6 mg/mL; 8 mg/mL; .4 m Liquid — NDC 58657-327-50 (Billing 58657-0327-50)

by Method Pharmaceuticals, LLC · 1 BOTTLE, DROPPER in 1 BOX / 50 mL in 1 BOTTLE, DROPPER

This is a package of Multi-Vitamin Drops with Fluoride and Iron VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, Ferrous sulfate and SODIUM 1500 [iU]/mL; 35 mg/mL; 400 [iU]/mL; 5 [iU]/mL; .5 mg/mL; 5'-PHOSPHATE SODIUM .6 mg/mL; 8 mg/mL; .4 m Liquid from Method Pharmaceuticals, LLC, marketed since Feb 2017 and currently FDA-listed; retail pharmacies pay about $0.1938 per mL (NADAC). It is this product's only package size.

NDC 58657-0327-50
🏷️ FDA NDC (as labeled) 58657-327-50 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 Oct 1, 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 58657-327-50 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
58657 labeler · 327 product · 50 package
Package marketed since
Feb 24, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5865732750 7
Medicaid fills, this package
4,205 prescriptions in the last four reported quarters
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58657-327-50
Product NDC 58657-327
11-digit billing NDC 58657032750
NCPDP billing unit ML — per mL (volume)
UNII 1D1K0N0VVC, PQ6CK8PD0R, 1C6V77QF41, LU4B53JYVE, M572600E5P, 20RD1DZH99 +4 more
SPL Set ID d5609742-e456-4409-bca9-706b0ea90d35
Established class (EPC) Vitamin C; Vitamin D
Chemical class Ascorbic Acid; Vitamin D
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-02-24
Route ORAL
Dosage form LIQUID
Substance VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FERROUS SULFATE; SODIUM FLUORIDE

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

GPI-14 78450000002008
GPI class Multi-Vitamin/Fluoride/Iron
GCN Seq No 072301
GCN 36455
HICL code 041114
Ingredient (HICL) Pedi Multivit 45/Fluoride/Iron
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6H
Therapeutic class — specific (HIC3) Pediatric Vitamin Preparations
AHFS code 20:04.04.00
AHFS class Iron Preparations
FDB label name MULTIVIT-FLUOR-IRON 0.25 MG/ML
FDB brand name Multi-Vitamin W-Fluoride-Iron
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Quick answers
  • GSN (GCN sequence number): 072301
  • GCN: 36455
  • GPI-14 (Medi-Span): 78450000002008
  • HICL (First Databank): 041114
  • AHFS class code: 20:04.04.00
Why two NDCs? The FDA registers this code as 58657-327-50 — 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 → 58657-0327-50. 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

Label name MULTIVIT-FLUOR-IRON 0.25 MG/ML Ingredient Pedi Multivit 45/Fluoride/Iron
🧪 What is this product?

This is a liquid oral supplement containing a combination of vitamins and minerals. Vitamin A, vitamin C (ascorbic acid), vitamin D (cholecalciferol), and vitamin E are typically included in multivitamins to support general nutritional needs. The B vitamins (thiamine, riboflavin, niacinamide, and pyridoxine) are commonly used to help support energy metabolism and nerve function. Ferrous sulfate is an iron source typically used to help address iron deficiency, and sodium fluoride is commonly included in pediatric vitamin drops to support dental health. 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 mLPer package
Retail pharmacies payNADAC · weekly $0.194 $9.69 / 50 ml
Medicaid paysCMS SDUD · 12 mo $0.2609 $13.05 / 50 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Nov 2021 Nov 2022 Apr 2026 Sep 2026 $0.238 $0.177
▼ Down 16% over the last 16 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
58657-0327-50 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 BOX / 50 mL in 1 BOTTLE, DROPPER 2017-02-24 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Multi-Vitamin Drops with Fluoride and Iron 1500 [iU]/mL; 35 mg/mL; 400 [iU]/mL; 5 [iU]/mL; .5 mg/mL; 5'-PHOSPHATE SODIUM .6 mg/mL; 8 mg/mL; .4 mthis 58657-0327-50 Method 1 bottle $0.194 — 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

🏛️
2017
On the market since
Feb 2017
📍
2026
Currently FDA-listed
9 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

FlavorOrange
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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

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, LLC
Labeler code58657
First marketedFeb 2017
Product typeHuman Prescription Drug
Portfolio78 products on file

More NDCs from Method Pharmaceuticals, LLC labeler code 58657

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 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling ⚠️ Precautions 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 179 words ▾

INDICATIONS AND USAGE Supplementation of the diet with vitamins A, C and D. Multi-Vitamin Drops with Fluoride and Iron 0.25 mg also provides fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.

The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Multi-Vitamin Drops with Fluoride 0.25 mg (See Dosage and Administration ). Multi-Vitamin Drops with Fluoride and Iron 0.25 mg supply significant amounts of vitamins A, C and D to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop.

Thus, in a single easy-to-use preparation, children obtain essential vitamins and fluoride.

⏱️ Dosage and Administration 97 words ▾

DOSAGE AND ADMINISTRATION: See following chart. May be dropped directly into the mouth with dropper; or mixed with cereal, fruit juice or other food. Fluoride Ion Level in Drinking Water (ppm) * A g e <0.3 ppm 0.3 - 0.6 ppm >0.6 ppm Birth - 6 months None None None 6 mos - 3 years 0.25 mg (1 mL) / day † None None 3 - 6 years 0.50 mg (2 mL) / day 0.25 mg (1 mL) / day None * 1.0 ppm = 1 mg/liter † 2.2 mg sodium fluoride contains 1 mg fluoride ion.

⚠️ Warnings 15 words ▾

WARNING S As in the case of all medications, keep out of reach of children.

🤒 Adverse Reactions 11 words ▾

ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported.

🧬 Clinical Pharmacology 147 words ▾

CLINICAL PHARMACOLOGY It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries. Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite.

The reaction may be expressed by the equation: Three stages of fluoride deposition in tooth enamel can be distinguished: Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.

After eruption, the surface enamel acquires fluoride from water, food, supplementary fluoride and smaller amounts from saliva. eq

📦 How Supplied / Storage and Handling 21 words ▾

HOW SUPPLIED Multi-Vitamin and Fluoride and Iron 0.25 mg drops is available in 50 mL bottles with accompanying calibrated dropper. dropper

⚠️ Precautions 210 words ▾

PRECAUTION S The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride. When prescribing vitamin fluoride products: Determine the fluoride content of the drinking water. Make sure the child is not receiving significant amounts of fluoride from other medications and swallowed toothpaste.

Periodically check to make sure that the child does not develop significant dental fluorosis. Multi-Vitamin Drops with Fluoride Iron 0.25 mg should be dispensed in the original plastic container, since contact with glass leads to instability and precipitation. (The amount of sodium fluoride in the 50 mL size is well below the maximum to be dispensed at one time according to recommendations of the American Dental Association.) Important Considerations When Using Dosage Schedule: If fluoride level is unknown, drinking water should be tested for fluoride content before supplements are prescribed.

For testing of fluoride content, contact the local or state health department. All sources of fluoride should be evaluated with a thorough fluoride history. Patient exposure to multiple water sources can make proper prescribing complex.

Ingestion of higher than recommended levels of fluoride by children has been associated with an increase in mild dental fluorosis in developing, unerupted teeth. Fluoride supplements require long-term compliance on a daily basis.

📚 References 208 words ▾

R E F E R E NC E S Brudevoid F, McCann HG: Fluoride and caries control - Mechanism of action, in Nizel AE (ed): The Science of Nutrition and its Application in Clinical Dentistry. Philadelphia, WB Saunders Co, 1966, pp 331-347. American Academy of Pediatrics Committee on Nutrition: Fluoride supplementation, Pediatrics American Dental Association Council on Dental Therapeutics: Accepted Dental Therapeutics , ed 38, Chicago, 1979, p321.

Hennon DK, Stookey GK, Muhler JC: The clinical anticariogenic effectiveness of supplementary fluoride-vitamin preparations - Results at the end of three years. J Dent Children 1966; 33 January: 3-12. Hennon DK, Stookey GK, Muhler JC: The clinical anticariogenic effectiveness of supplementary fluoride-vitamin preparations - Results at the end of four years.

J Dent Children 1967; 34 November; 439- 443. Hennon DK, Stookey GK, Muhler JC: The clinical anticariogenic effectiveness of supplementary fluoride-vitamin preparations - Results at the end of five and a half years. Phar and Ther in Dent 1970; 1:1.

Hennon DK, Stookey GK, Beiswanger BB: Fluoride-vitamin supplements: Effects on dental caries and fluorosis when used in areas with suboptimum fluoride in the water supply. J Am Dent Assoc 1977; 95-965 1986; 77:758. Distributed by: Method Pharmaceuticals, LLC Fort Worth, TX 76118 877-250-3427 Rev.

01/17 Made in the USA

📄 Package Label / Principal Display Panel 22 words ▾

PRINCIPAL DISPLAY PANEL NDC 58657-327-50 Multi- Vitamin Drops With Fluoride & Iron 0.25 mg

1.69FL. OZ. (50 mL) Rx Only carton

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
4.2K
Units reimbursed last 4 qtrs
218.2K
Gross reimbursed last 4 qtrs
$56.9K
Avg / prescription
$13.54
Avg / unit
$0.2609
Latest quarter Q1 2026
911Rx
Medicaid pays / mL
$0.2609
gross reimbursed
vs
NADAC / mL
$0.1938
acquisition cost
=
Spread
+$0.0671
+35% vs cost
What Medicaid paid per mL (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 ⓘ
92% MCO
Fee-for-service · 326 Rx Managed care · 3,879 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 1,300 units · 16.6 per 100k residents 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: 6,960 units · 69.3 per 100k residents MI New York: 15,080 units · 77.1 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 5,500 units · 130 per 100k residents 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: 2,850 units · 24.2 per 100k residents OH Pennsylvania: 14,300 units · 110 per 100k residents PA New Jersey: 109,560 units · 1,179 per 100k residents NJ Massachusetts: 18,350 units · 262 per 100k residents MA California: 650 units · 1.7 per 100k residents CA Utah: 1,500 units · 43.9 per 100k residents UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 2,650 units · 42.9 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 600 units · 8.4 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 18,600 units · 407 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: 2,950 units · 206 per 100k residents HI Texas: 17,320 units · 56.8 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.71,179
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 New Jersey 1,179 /100k
2 Louisiana 407 /100k
3 Massachusetts 262 /100k
4 Hawaii 206 /100k
5 Oregon 130 /100k
6 Pennsylvania 110 /100k
7 New York 77.1 /100k
8 Michigan 69.3 /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.

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, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Method Pharmaceuticals, LLC 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.
← 58657-0326-50 · Method 58657-0403-01 · 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.