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Hydroquinone 40 mg/g Cream, 1 tube — NDC 69367-0174-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hydroquinone 40 mg/g Cream, 1 tube — NDC 69367-174-01 (Billing 69367-0174-01)

by Westminster Pharmaceuticals, LLC · 1 TUBE in 1 CARTON / 28.35 g in 1 TUBE

This is a package of 1 tube of Hydroquinone 40 mg/g Cream from Westminster Pharmaceuticals, LLC, marketed since Apr 2018 and currently FDA-listed; retail pharmacies pay about $0.5130 per g (NADAC). It is this product's only package size.

NDC 69367-0174-01
🏷️ FDA NDC (as labeled) 69367-174-01 billing pads the product segment with a zero
Rx only 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 69367-174-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
69367 labeler · 174 product · 01 package
Package marketed since
Apr 16, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6936717401 5
Medicaid fills, this package
2,368 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
Past resolved recalls for this product (2)
Class II · Sep 23, 2021 · Terminated — Finished product specification did not meet USP specifications. (Monarch PCM, LLC) · FDA recall D-0855-2021
Class III · Sep 1, 2021 · Terminated — Subpotency: one product for active ingredient assay and another one for preservative assay (Monarch PCM, LLC) · FDA recall D-0818-2021

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69367-174-01
Product NDC 69367-174
11-digit billing NDC 69367017401
NCPDP billing unit GM — per gram (weight)
RxCUI 197795
UNII XV74C1N1AE
SPL Set ID dc72c0b2-4505-4dcf-8a69-889cd9f41693
Established class (EPC) Melanin Synthesis Inhibitor
Mechanism of action Melanin Synthesis Inhibitors
Physiologic effect Depigmenting Activity
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-04-16
Route TOPICAL
Dosage form CREAM
Substance HYDROQUINONE

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

GPI-14 90872010003720
GPI class Hydroquinone
GCN Seq No 006313
GCN 24883
HICL code 002721
Ingredient (HICL) Hydroquinone
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L9
Therapeutic class — intermediate (HIC2) Dermatologic Preparations,Miscellaneous
HIC3 code L9C
Therapeutic class — specific (HIC3) Hypopigmentation Agents
AHFS code 84:50.04.00
AHFS class Depigmenting Agents
FDB label name HYDROQUINONE 4% CREAM
FDB brand name Hydroquinone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 006313
  • GCN: 24883
  • GPI-14 (Medi-Span): 90872010003720
  • HICL (First Databank): 002721
  • AHFS class code: 84:50.04.00
  • RxCUI (RxNorm): 197795
Why two NDCs? The FDA registers this code as 69367-174-01 — 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 → 69367-0174-01. 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 Melanin Synthesis Inhibitor class.

Pharmacologic class Melanin Synthesis Inhibitor
Drug family (ATC) Other dermatologicals
How it works Melanin Synthesis Inhibitors
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 HYDROQUINONE 4% CREAM Ingredient Hydroquinone
🧪 What is this product?

This is a topical cream containing hydroquinone 40 mg per gram, marketed as a prescription product. Hydroquinone is typically used in skin-lightening formulations to reduce the appearance of dark patches or discoloration on the skin by inhibiting melanin production. This product is an unapproved drug and has not received FDA approval for marketing in the United States.

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 gPer package
Retail pharmacies payNADAC · weekly $0.513 $14.54 / 28.35 g
Medicaid paysCMS SDUD · 12 mo $0.8570 $24.30 / 28.35 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $1.165 $0.513
▼ Down 53% over the last 24 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
69367-0174-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 28.35 g in 1 TUBE 2018-04-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydroquinone 4% 40 mg/g 75834-0137-01 Nivagen 1 tube $0.461 — Availability likely save 10%
Hydroquinone 4% 40 mg/g 42192-0151-01 Acella 1 tube $0.513 — Availability likely —
Hydroquinone 40 mg/gthis 69367-0174-01 Westminster 1 tube $0.513 — Availability likely —
hydroquinone 40 mg/g 10135-0724-99 Marlex 1 tube — — FDA listed —
Hydroquinone cream 40 mg/g 24689-0101-01 APNAR 1 tube — — FDA listed —
Hydroquinone 4% 40 mg/g 50405-0800-01 SOHM, 1 tube — — FDA listed —
NU-DERM BLENDER Skin Lightener and Blending 40 mg/g 62032-0100-10 Obagi 28 g — — FDA listed —
NU-DERM CLEAR Skin Bleaching and Corrector 40 mg/g 62032-0101-36 Obagi 57 g — — FDA listed —
Obagi-C Rx system C-Therapy Night Skin Lightening with Vitamins C and E 40 mg/g 62032-0105-36 Obagi 57 g — — FDA listed —
NU-DERM SUNFADER Skin Lightener with Sunscreen (SPF 15) PABA FREE 40 mg/g; 75 mg/g; 55 mg/g 62032-0116-36 Obagi 57 g — — FDA listed —
Hydroquinone 4% 40 mg/g 71399-0400-01 Akron 28.35 g — — FDA listed —
Hydroquinone 4% 40 mg/g 72162-2422-02 Bryant 1 tube — — FDA listed —
Hydro-Q 40 mg/g 30815-0040-01 Dermavance 1 tube — — 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

🏛️
2018
On the market since
Apr 2018
📍
2026
Currently FDA-listed
8 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.

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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII X21KPH4633
    A synthetic compound made from propylene glycol and stearic acid, combined with polyethylene glycol. It acts as an emulsifier and surfactant to help blend oil and water-based ingredients and improve texture in liquid or semi-solid medications.
  • UNII 13A4J4NH9I
    A synthetic emulsifier derived from stearic acid and polyethylene glycol. It helps mix oil and water-based ingredients together in liquid medicines and creams to create a smooth, uniform product.
  • 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 4VON5FNS3C
    Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • 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.

10 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

LabelerWestminster Pharmaceuticals, LLC
Labeler code69367
First marketedApr 2018
Product typeHuman Prescription Drug
Portfolio186 products on file

More NDCs from Westminster Pharmaceuticals, LLC labeler code 69367

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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 33 words ▾

INDICATIONS AND USAGE HYDROQUINONE USP, 4% SKIN BLEACHING CREAM is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

⏱️ Dosage and Administration 72 words ▾

DOSAGE AND ADMINISTRATION HYDROQUINONE USP, 4% SKIN BLEACHING CREAM should be applied to affected areas and rubbed in well twice daily, in the morning and before bedtime, or as directed by a physician. If no improvement is seen after 2 months of treatment, use of this product should be discontinued. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.

⛔ Contraindications 38 words ▾

CONTRAINDICATIONS Prior history of sensitivity or allergic reaction to hydroquinone or to any of the ingredients of the product. The safety of topical hydroquinone use during pregnancy or for children (12 years and under) has not been established.

⚠️ Warnings 130 words ▾

WARNINGS Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

Since this product contains no sunscreen, an effective broad spectrum sun blocking agent should be used and unnecessary solar exposure avoided, or protective clothing should be worn to cover bleached skin in order to prevent repigmentation from occurring. Hydroquinone may produce exogenous ochronosis, a gradual blue-black darkening of the skin. If this condition occurs, discontinue treatment and consult your physician.

The majority of patients developing this condition are Black, but it may also occur in Caucasians and Hispanics.

🤒 Adverse Reactions 40 words ▾

ADVERSE REACTIONS The following adverse reactions have been reported: dryness and fissuring of paranasal and infraorbital areas, erythema, and stinging. Occasional hypersensitivity (localized contact dermatitis) may develop. If this occurs, the medication should be discontinued and the physician notified immediately.

🔄 Drug Interactions 16 words ▾

Drug Interactions Patients are cautioned on concomitant use of medications that are known to be photosensitizing.

🤰 Pregnancy 52 words ▾

Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether topical hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Topical hydroquinone should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 18 words ▾

Pediatric Use Safety and effectiveness for pediatric patients below the age of 12 years have not been established.

🆘 Overdosage 47 words ▾

OVERDOSAGE There have been no systemic reactions reported from the use of topical hydroquinone. However, treatment should be limited to relatively small areas of the body at one time, since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment.

🧬 Clinical Pharmacology 63 words ▾

CLINICAL PHARMACOLOGY Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine (dopa) (Denton, C. et al., 1952) 1 and suppression of other melanocyte metabolic processes (Jimbow, K. et al., 1974) 2 . Exposure to sunlight or ultraviolet light will cause repigmentation of bleached areas (Parrish, J.A. et al., 1978) 3 .

📦 How Supplied / Storage and Handling 112 words ▾

HOW SUPPLIED HYDROQUINONE USP, 4% SKIN BLEACHING CREAM is available in a 1 oz (28.35 g) tube with (NDC 69367-174-01) Store at 20°C-25°C (68°F-77°F) [see USP Controlled Room Temperature]. All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic or other equivalency testing.

No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information provided herein.

📦 Storage and Handling 92 words ▾

Store at 20°C-25°C (68°F-77°F) [see USP Controlled Room Temperature]. All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic or other equivalency testing.

No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information provided herein.

📋 Description 66 words ▾

DESCRIPTION Each gram of HYDROQUINONE USP, 4% SKIN BLEACHING CREAM contains 40 mg hydroquinone, in a cream base of Glyceryl Monostearate, Mineral Oil, PEG-25 Propylene Glycol Stearate, Polyoxl-40 Stearate, Propylene Glycol, Propylparaben, Purified water, sodium metabisulfite, Squalane and Stearic Acid. Chemically, hydroquinone is C6H6O2 and has a molecular weight of 110.11. The chemical name is 1,4 dihydroxybenzene, and the structural formula of hydroquinone is: Chemical Structure

💬 Information for Patients 83 words ▾

Information for Patients Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight sustains melanocytic activity. To prevent repigmentation, during treatment and maintenance therapy, sun exposure on treated skin should be avoided by application of a broad spectrum sunscreen (SPF 15 or greater) or by use of protective clothing. Avoid contact with eyes and mucous membranes.

Keep this and all medications out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS (see WARNINGS ) General Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin; check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response further treatment is not advised. Close patient supervision is recommended.

Hydroquinone is a skin bleaching agent which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication. Information for Patients Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight sustains melanocytic activity.

To prevent repigmentation, during treatment and maintenance therapy, sun exposure on treated skin should be avoided by application of a broad spectrum sunscreen (SPF 15 or greater) or by use of protective clothing. Avoid contact with eyes and mucous membranes. Keep this and all medications out of reach of children.

In case of accidental ingestion, call a physician or a poison control center immediately. Drug Interactions Patients are cautioned on concomitant use of medications that are known to be photosensitizing. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity.

The carcinogenic potential of hydroquinone in humans is unknown. Published studies have demonstrated that hydroquinone is a mutagen and a clastogen. Treatment with hydroquinone has resulted in positive findings for genetic toxicity in the Ames assay in bacterial strains sensitive to oxidizing mutagens, in in vitro studies in mammalian cells, and in the in vivo mouse micronucleus assay.

Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether topical hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Topical hydroquinone should be given to a pregnant woman only if clearly needed.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when topical hydroquinone is administered to a nursing woman. Pediatric Use Safety and effectiveness for pediatric patients below the age of 12 years have not been established.

🍼 Nursing Mothers 35 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when topical hydroquinone is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 74 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown. Published studies have demonstrated that hydroquinone is a mutagen and a clastogen.

Treatment with hydroquinone has resulted in positive findings for genetic toxicity in the Ames assay in bacterial strains sensitive to oxidizing mutagens, in in vitro studies in mammalian cells, and in the in vivo mouse micronucleus assay.

📄 Package Label / Principal Display Panel 33 words ▾

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton NDC 69367-174-01 Rx Only Hydroquinone USP, 4% Skin Bleaching Cream Westminster Pharmaceuticals Net Wt 1 oz (28.35g) Principal Display Panel - 28.35 g Tube 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
2.4K
Units reimbursed last 4 qtrs
73.8K
Gross reimbursed last 4 qtrs
$63.2K
Avg / prescription
$26.70
Avg / unit
$0.8570
Latest quarter Q1 2026
475Rx
Medicaid pays / g
$0.8570
gross reimbursed
vs
NADAC / g
$0.5130
acquisition cost
=
Spread
+$0.3440
+67% vs cost
What Medicaid paid per g (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 ⓘ
60% FFS 40% MCO
Fee-for-service · 1,430 Rx Managed care · 938 Rx
State Medicaid map
Alaska: 369 units · 50.3 per 100k residents 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: 6,521 units · 52.0 per 100k residents IL Indiana: no data reported IN Ohio: 6,719 units · 57.0 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: no data reported NE Missouri: no data reported MO Kentucky: 12,099 units · 267 per 100k residents KY West Virginia: no data reported WV Virginia: 397 units · 4.6 per 100k residents VA Maryland: no data reported MD Connecticut: 45,955 units · 1,271 per 100k residents 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: no data reported TN North Carolina: 1,275 units · 11.8 per 100k residents 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: 425 units · 1.9 per 100k residents FL
Units reimbursed · per 100k residents
1.91,271
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 Connecticut 1,271 /100k
2 Kentucky 267 /100k
3 Ohio 57.0 /100k
4 Illinois 52.0 /100k
5 Alaska 50.3 /100k
6 North Carolina 11.8 /100k
7 Virginia 4.6 /100k
8 Florida 1.9 /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 Westminster Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Westminster 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.
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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.