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Hydroxyzine Hydrochloride 25 mg Tablet, Film Coated — NDC 00904-6617-61 package photo

Hydroxyzine Hydrochloride 25 mg Tablet, Film Coated

by Major Pharmaceuticals · 100 BLISTER PACK in 1 CARTON (0904-6617-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
NDC 00904-6617-61
🏷️ FDA NDC (as labeled) 0904-6617-61 billing pads the labeler segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced 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

⚠️
Other active recalls for Hydroxyzine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Jun 2, 2026 — Presence of foreign substance (ANI Pharmaceuticals, Inc.) · FDA recall D-0619-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 0904-6617-61
Product NDC 0904-6617
11-digit billing NDC 00904661761
NCPDP billing unit EA — each (per item)
RxCUI 995258, 995281
UNII 76755771U3
Application # ANDA040604
SPL Set ID 7534a3bb-b4cd-415f-8612-53b37dc6d55f
Established class (EPC) Antihistamine
Mechanism of action Histamine Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2026)
Marketing start 2015-03-31
Marketing end 2026-08-31
Route ORAL
Dosage form TABLET, FILM COATED
Substance HYDROXYZINE HYDROCHLORIDE
GCN Seq No 003728
GCN 13943
HICL code 001608
Ingredient (HICL) Hydroxyzine Hcl
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2P
Therapeutic class — specific (HIC3) Antihistamines - 1St Generation
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name HYDROXYZINE HCL 25 MG TABLET
FDB brand name Hydroxyzine Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0904-6617-61 — 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 → 00904-6617-61. 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 Antihistamine class.

Pharmacologic class Antihistamine
Drug family (ATC) Diphenylmethane derivatives
How it works Histamine Receptor Antagonists
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.

🏭 Manufacturer & labeler

LabelerMajor Pharmaceuticals
Application holderEPIC PHARMA LLC
FDA applicationANDA040604 (ANDA)
Labeler code00904
First marketedMar 2015
Product typeHuman Prescription Drug
Portfolio629 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.

🩺 Clinical

Label name HYDROXYZINE HCL 25 MG TABLET Ingredient Hydroxyzine Hcl
📖 What it is MedlinePlus · NLM

Hydroxyzine is used to relieve itching caused by allergic skin reactions, to relieve anxiety and tension, and as a sedative before and after general anesthesia for surgery. Hydroxyzine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. It also works by decreasing activity in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Hydroxyzine is most often used to relieve anxiety and tension, or to control itching from allergic conditions like hives or eczema. It's also used as a calming medication before su...
  • Drowsiness is the most common side effect — it's actually how the medication works, so some sleepiness is expected, especially when you first start. For most people it gets better...
  • This is really important to go over with your pharmacist or doctor, because hydroxyzine interacts with a number of common drugs. Combining it with alcohol, opioid pain medicines, s...
  • Can I take hydroxyzine with my other medications?
📖 Read our full Hydroxyzine 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.

💊 What it looks like

Color Green / Yellow
ShapeRound
Imprint161
Size9 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 R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • UNII 4AQJ3LG584
    A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
  • 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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 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 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 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • 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 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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.

14 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.

💲 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 $0.034 $3.42 / 100 tablet
Medicaid paysCMS SDUD · 12 mo $3.10 $309.63 / 100 tablet
Medicare drug plans payPart D · Q2 2026 $0.1378 $13.78 / 100 tablet
Medicare Part B allowsASP · Q0177 No ASP payment limit on file for Q0177 this quarter.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.076 $0.034
▼ Down 28% 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.

🧾 Billing & reimbursement

FDA NDC (as labeled)0904-6617-61
11-digit billing NDC00904-6617-61
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeQ0177
DescriptorHYDROXYZINE PAMOATE, 25 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN
Billing units / pkg1 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydroxyzine Hydrochloride 25 mg 00093-5061-01 Teva 100 tablets $0.034 AB Availability likely —
Hydroxyzine Hydrochloride 25 mgthis 00904-6617-61 Major 1 tablet $0.034 AB Discontinued —
Hydroxyzine hydrochloride 25 mg 00904-7378-40 Major 500 tablets $0.034 AB Availability likely —
Hydroxyzine Hydrochloride 25 mg 10702-0011-01 KVK-Tech, 100 tablets $0.034 AB Availability likely —
Hydroxyzine Hydrochloride 25 mg 16571-0114-01 Rising 100 tablets $0.034 AB Availability likely —
HydrOXYzine Hydrochloride 25 mg 16714-0082-10 Northstar 100 tablets $0.034 AB Availability likely —
Hydroxyzine hydrochloride 25 mg 23155-0501-01 Heritage 100 tablets $0.034 AB Availability likely —
Hydroxyzine Hydrochloride 25 mg 24658-0782-10 PURACAP 1000 tablets $0.034 AB Availability likely —
Hydroxyzine Hydrochloride 25 mg 42806-0160-01 Epic 100 tablets $0.034 AB Availability likely —
Hydroxyzine Hydrochloride 25 mg 59651-0500-01 Aurobindo 100 tablets $0.034 — Availability likely —
Hydroxyzine Hydrochloride 25 mg 60687-0675-01 American 1 tablet $0.034 AB Availability likely —
Hydroxyzine Hydrochloride 25 mg 62135-0574-05 Chartwell 500 tablets $0.034 AB Availability likely —
Hydroxyzine hydrochloride 25 mg 00615-8082-05 NCS 15 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 10135-0811-01 Marlex 100 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 11534-0205-01 Sunrise 100 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 31722-0501-01 Camber 100 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 43063-0518-06 PD-Rx 6 tablets — — FDA listed —
Hydroxyzine Hydrochloride 25 mg 43063-0627-28 PD-Rx 28 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 43063-0962-01 PD-Rx 100 tablets — — FDA listed —
Hydroxyzine hydrochloride 25 mg 45865-0675-20 Medsource 20 tablets — AB FDA listed —
Hydroxyzine hydrochloride 25 mg 50090-2648-00 A-S 20 tablets — AB FDA listed —
Hydroxyzine hydrochloride 25 mg 50090-3583-01 A-S 28 tablets — AB FDA listed —
Hydroxyzine hydrochloride 25 mg 50090-5297-00 A-S 90 tablets — AB FDA listed —
Hydroxyzine hydrochloride 25 mg 50090-6624-00 A-S 90 tablets — AB FDA listed —
HydrOXYzine Hydrochloride 25 mg 50090-6626-00 A-S 90 tablets — AB FDA listed —
HydrOXYzine Hydrochloride 25 mg 50090-6628-00 A-S 90 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 50090-6653-01 A-S 28 tablets — — FDA listed —
Hydroxyzine Hydrochloride 25 mg 50090-6655-00 A-S 20 tablets — — FDA listed —
Hydroxyzine Hydrochloride 25 mg 50090-6657-00 A-S 90 tablets — — FDA listed —
Hydroxyzine Hydrochloride 25 mg 50090-6659-00 A-S 90 tablets — — FDA listed —
Hydroxyzine Hydrochloride 25 mg 50090-7034-00 A-S 1 tablet — — FDA listed —
Hydroxyzine Hydrochloride 25 mg 50090-7327-00 A-S 90 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 50090-7329-00 A-S 90 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 50090-7330-00 A-S 20 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 50090-7331-00 A-S 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 50090-7332-00 A-S 30 tablets — AB FDA listed —
HydrOXYzine Hydrochloride 25 mg 50090-7582-01 A-S 28 tablets — AB FDA listed —
Hydroxyzine hydrochloride 25 mg 51407-0970-10 Golden 1000 tablets — AB FDA listed —
Hydroxyzine hydrochloride 25 mg 51655-0080-20 Northwind 20 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 51655-0589-52 Northwind 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 55154-2148-00 Cardinal 1 tablet — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 55154-7994-00 Cardinal 1 tablet — AB Discontinued —
Hydroxyzine Hydrochloride 25 mg 60760-0971-30 St. 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 60760-0990-30 St. 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 62135-0546-05 Chartwell 500 tablets — AB FDA listed —
Hydroxyzine hydrochloride 25 mg 63187-0733-20 Proficient 20 tablets — AB FDA listed —
Hydroxyzine hydrochloride 25 mg 63629-1856-01 Bryant 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 63629-8740-01 Bryant 100 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 65162-0671-10 Amneal 100 tablets — — FDA listed —
Hydroxyzine hydrochloride 25 mg 67046-0713-03 Coupler 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 67046-1311-03 Coupler 30 tablets — AB FDA listed —
HydrOXYzine Hydrochloride 25 mg 68071-2237-02 NuCare 20 tablets — AB FDA listed —
HydrOXYzine Hydrochloride 25 mg 68071-3450-04 NuCare 4 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 68071-3964-03 NuCare 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 68071-4622-03 NuCare 30 tablets — — FDA listed —
Hydroxyzine hydrochloride 25 mg 68071-5286-03 NuCare 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 68071-5296-06 NuCare 6 tablets — AB FDA listed —
Hydroxyzine hydrochloride 25 mg 68788-7854-03 Preferred 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 68788-8707-03 Preferred 30 tablets — AB FDA listed —
Hydroxyzine hydrochloride 25 mg 70518-1692-01 REMEDYREPACK 15 tablets — AB Discontinued —
Hydroxyzine Hydrochloride 25 mg 70518-1730-01 REMEDYREPACK 30 tablets — — Discontinued —
Hydroxyzine Hydrochloride 25 mg 70518-2066-00 REMEDYREPACK 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 70518-2279-01 REMEDYREPACK 30 tablets — AB Discontinued —
Hydroxyzine Hydrochloride 25 mg 70518-4141-00 REMEDYREPACK 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 71205-0155-20 Proficient 20 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 71205-0273-15 Proficient 15 tablets — — FDA listed —
Hydroxyzine Hydrochloride 25 mg 71335-0935-01 Bryant 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 71335-1047-01 Bryant 30 tablets — — FDA listed —
Hydroxyzine hydrochloride 25 mg 71335-2340-01 Bryant 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 71335-2451-01 Bryant 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 71335-2776-01 Bryant 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 71335-3035-01 Bryant 1000 tablets — AB FDA listed —
HydrOXYzine Hydrochloride 25 mg 71610-0686-53 Aphena 60 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 71610-0735-30 Aphena 30 tablets — — FDA listed —
Hydroxyzine hydrochloride 25 mg 71610-0844-53 Aphena 60 tablets — AB FDA listed —
Hydroxyzine hydrochloride 25 mg 71610-0851-30 Aphena 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 72162-1333-02 Bryant 20 tablets — — FDA listed —
Hydroxyzine Hydrochloride 25 mg 72162-2512-00 Bryant 1000 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 72789-0216-12 PD-Rx 12 tablets — AB FDA listed —
Hydroxyzine hydrochloride 25 mg 76420-0882-01 Asclemed 100 tablets — AB FDA listed —
Hydroxyzine hydrochloride 25 mg 80425-0365-01 Advanced 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 25 mg 71335-3061-01 Bryant 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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
Mar 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🗺️ 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 00904-6617-61, 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 – Q4 2025 · 4 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
2.5K
Units reimbursed last 4 qtrs
5.4K
Gross reimbursed last 4 qtrs
$16.6K
Avg / prescription
$6.77
Avg / unit
$3.0963
Latest quarter Q4 2025
193Rx
Medicaid pays / ea
$3.0963
gross reimbursed
vs
NADAC / ea
$0.0342
acquisition cost
=
Spread
+$3.0621
+8954% 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 ⓘ
26% FFS 74% MCO
Fee-for-service · 629 Rx Managed care · 1,825 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 81 units · 1.0 per 100k residents WA Idaho: no data reported ID Montana: 70 units · 6.2 per 100k residents MT North Dakota: 46 units · 5.9 per 100k residents ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 40 units · 0.4 per 100k residents MI New York: 766 units · 3.9 per 100k residents NY Vermont: no data reported VT New Hampshire: 216 units · 15.4 per 100k residents NH Oregon: 86 units · 2.0 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 128 units · 13.9 per 100k residents SD Iowa: 17 units · 0.5 per 100k residents IA Illinois: no data reported IL Indiana: 51 units · 0.7 per 100k residents IN Ohio: 35 units · 0.3 per 100k residents OH Pennsylvania: 46 units · 0.4 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 640 units · 9.1 per 100k residents MA California: 1,509 units · 3.9 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 29 units · 1.5 per 100k residents NE Missouri: 410 units · 6.6 per 100k residents MO Kentucky: 820 units · 18.1 per 100k residents KY West Virginia: no data reported WV Virginia: 82 units · 0.9 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 132 units · 6.2 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 146 units · 2.0 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: 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: 14 units · 1.0 per 100k residents HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.318.1
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 Kentucky 18.1 /100k
2 New Hampshire 15.4 /100k
3 South Dakota 13.9 /100k
4 Massachusetts 9.1 /100k
5 Missouri 6.6 /100k
6 New Mexico 6.2 /100k
7 Montana 6.2 /100k
8 North Dakota 5.9 /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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00904-6617-61 You're viewing this 100 BLISTER PACK in 1 CARTON (0904-6617-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK 2015-03-31 Active

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 ✓ Available
HCPCS J-code billing crosswalk ✓ Available
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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 FDA registers it as 0904-6617-61, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00904-6617-61, written without dashes as 00904661761. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00904-6617-61, the first segment (00904) is the labeler code FDA assigned to Major Pharmaceuticals; the middle segment (6617) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (61) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Major 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code Q0177 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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📄 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 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 155 words ▾

INDICATIONS AND USAGE For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis.

Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies.

The physician should reassess periodically the usefulness of the drug for the individual patient.

⏱️ Dosage and Administration 165 words ▾

DOSAGE AND ADMINISTRATION For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: adults, 50 to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 100 mg daily in divided doses. For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus: adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 100 mg daily in divided doses.

As a sedative when used as a premedication and following general anesthesia: 50 to 100 mg for adults and 0.6 mg/kg of body weight in children. When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally. As with all potent medication, the dosage should be adjusted according to the patient's response to therapy.

⛔ Contraindications 104 words ▾

CONTRAINDICATIONS Oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride. Hydroxyzine is contraindicated in patients with a prolonged QT interval. Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range.

Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy. Hydroxyzine is contraindicated for patients who have shown a previous hypersensitivity to any component of this medication.

⚠️ Warnings 29 words ▾

WARNINGS Nursing Mothers It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.

🤒 Adverse Reactions 128 words ▾

ADVERSE REACTIONS Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. Anticholinergic: Dry mouth. Central Nervous System: Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of dose.

Involuntary motor activity including rare instances of tremor and convulsions have been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses. Cardiac System: QT prolongation, Torsade de Pointes.

In postmarketing experience, the following additional undesirable effects have been reported: Body as a Whole: Allergic reaction. Nervous System: Headache. Psychiatric: Hallucination.

Skin and Appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in postmarketing reports. Pruritus, rash, urticaria.

🧓 Geriatric Use 142 words ▾

Geriatric Use A determination has not been made whether controlled clinical studies of hydroxyzine included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

The extent of renal excretion of hydroxyzine has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections. Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of hydroxyzine and observed closely.

🆘 Overdosage 174 words ▾

OVERDOSAGE The most common manifestation of hydroxyzine overdosage is hypersedation. Other reported signs and symptoms were convulsions, stupor, nausea and vomiting. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.

If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated.

Hypotension, though unlikely, may be controlled with intravenous fluids and levarterenol or metaraminol. Do not use epinephrine as hydroxyzine counteracts its pressor action. Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes.

ECG monitoring is recommended in cases of hydroxyzine overdose. There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with hydroxyzine.

However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate hydroxyzine in body fluids or tissue after its ingestion or administration

🧬 Clinical Pharmacology 130 words ▾

CLINICAL PHARMACOLOGY Hydroxyzine hydrochloride is unrelated chemically to the phenothiazines, reserpine, meprobamate or the benzodiazepines. Hydroxyzine is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system. Primary skeletal muscle relaxation has been demonstrated experimentally.

Bronchodilator activity, and antihistaminic and analgesic effects have been demonstrated experimentally and confirmed clinically. An antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated. Pharmacological and clinical studies indicate that hydroxyzine in therapeutic dosage does not increase gastric secretion or acidity and in most cases has mild antisecretory activity.

Hydroxyzine is rapidly absorbed from the gastrointestinal tract and hydroxyzine’s clinical effects are usually noted within 15 to 30 minutes after oral administration.

📦 How Supplied / Storage and Handling 187 words ▾

HOW SUPPLIED Hydroxyzine Hydrochloride Tablets USP, 25 mg are available as 10/32", Green round biconvex film-coated tablets debossed “Є” above “160” on one side and plain on the other side, packaged Cartons of 100 film-coated tablets (10 film-coated tablets each blister pack x 10), NDC 0904-6617-61 Hydroxyzine Hydrochloride Tablets USP, 50 mg are available as 11/32", Yellow round biconvex film-coated tablets, debossed “Є” above “161” on one side and plain on the other side, packaged Cartons of 100 film-coated tablets (10 film-coated tablets each blister pack x 10), NDC 0904-6618-61 WARNING: These Unit Dose packages are not child resistant and are Intended for Institutional Use Only.

Keep this and all drugs out of the reach of children. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Packaged and Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 USA Refer to package label for Distributor's NDC Number Manufactured in USA Rev. 01-2023-00 MF159REV01/23 OE1518

📋 Description 122 words ▾

DESCRIPTION Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-( p -Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C 21 H 27 CIN 2 O 2 ·2HCl M.W. 447.83 Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water.

Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include carnauba wax, colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, D&C Yellow #10 Aluminum Lake (25 mg and 50 mg), FD&C Blue #2 Aluminum Lake (25 mg), FD&C Red #40 Aluminum Lake (50 mg), FD&C Yellow #6 Aluminum Lake (10 mg and 50 mg), hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide, triacetin and yellow iron oxide (10 mg).

Structural Formula

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00904-6615-61 · Major 00904-6618-61 · Major →
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.