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Hydroxyzine hydrochloride 25 mg Tablet, 1,000-count — NDC 00904-7378-80 package photo

Hydroxyzine hydrochloride 25 mg Tablet, 1,000-count

by Major Pharmaceuticals · 1000 TABLET in 1 BOTTLE (0904-7378-80)
NDC 00904-7378-80
🏷️ FDA NDC (as labeled) 0904-7378-80 billing pads the labeler segment with a zero
This package
Contains1,000-count Cost per ea$0.0326 NADAC Per package$32.60 / 1000 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.4335/unit · Part D plans $0.1378/unit — full pricing hub ↓
Also comes in: 500 tablets 00904-7378-40
Rx only Generic On market Non-controlled
🗂️ Data synced Aug 6, 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 ↗

🆔 Identity & classification

FDA NDC (as labeled) 0904-7378-80
Product NDC 0904-7378
11-digit billing NDC 00904737880
NCPDP billing unit EA — each (per item)
RxCUI 995218, 995258, 995281
UNII 76755771U3
Application # ANDA204279
SPL Set ID 7f76580c-96a0-4b56-8986-ff5488bb9869
Established class (EPC) Antihistamine
Mechanism of action Histamine Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-08-01
Marketing end 2028-04-30
Route ORAL
Dosage form TABLET
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 0904-7378-80 — 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 → 00904-7378-80. 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 holderHERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC
FDA applicationANDA204279 (ANDA)
Labeler code00904
First marketedAug 2023
Product typeHuman Prescription Drug
Portfolio630 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
📗 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 White
ShapeRound
ImprintH;502
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 $0.033 $32.60 / 1000 tablets
Medicaid paysCMS SDUD · 12 mo $0.4335 $433.50 / 1000 tablets
Medicare drug plans payPart D · Q2 2026 $0.1378 $137.80 / 1000 tablets
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 2023 Jan 2026 May 2026 Sep 2026 $0.047 $0.033
▼ Down 30% over the last 13 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)0904-7378-80
11-digit billing NDC00904-7378-80
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 $0.033 AB Availability likely —
Hydroxyzine hydrochloride 25 mgthis 00904-7378-80 Major 1000 tablets $0.033 AB Availability likely —
Hydroxyzine Hydrochloride 25 mg 10702-0011-01 KVK-Tech, 100 tablets $0.033 AB Availability likely —
Hydroxyzine Hydrochloride 25 mg 16571-0114-01 Rising 100 tablets $0.033 AB Availability likely —
HydrOXYzine Hydrochloride 25 mg 16714-0082-10 Northstar 100 tablets $0.033 AB Availability likely —
Hydroxyzine hydrochloride 25 mg 23155-0501-01 Heritage 100 tablets $0.033 AB Availability likely —
Hydroxyzine Hydrochloride 25 mg 24658-0782-10 PURACAP 1000 tablets $0.033 AB Availability likely —
Hydroxyzine Hydrochloride 25 mg 59651-0500-01 Aurobindo 100 tablets $0.033 — Availability likely —
Hydroxyzine Hydrochloride 25 mg 60687-0675-01 American 1 tablet $0.033 AB Availability likely —
Hydroxyzine Hydrochloride 25 mg 62135-0574-05 Chartwell 500 tablets $0.033 AB Availability likely —
Hydroxyzine Hydrochloride 25 mg 00904-6617-61 Major 1 tablet $0.034 AB Discontinued +5%
Hydroxyzine Hydrochloride 25 mg 42806-0160-01 Epic 100 tablets $0.034 AB Availability likely +5%
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

🏛️
2023
On the market since
Aug 2023
📍
2026
Currently FDA-listed
3 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 00904-7378-80, 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
1.8K
Units reimbursed last 4 qtrs
99.4K
Gross reimbursed last 4 qtrs
$43.1K
Avg / prescription
$24.47
Avg / unit
$0.4335
Latest quarter Q1 2026
497Rx
Medicaid pays / ea
$0.4335
gross reimbursed
vs
NADAC / ea
$0.0326
acquisition cost
=
Spread
+$0.4009
+1230% 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 ⓘ
99% FFS
Fee-for-service · 1,735 Rx Managed care · 26 Rx
State Medicaid map
Alaska: 97,254 units · 13,268 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: no data reported IL Indiana: no data reported IN Ohio: no data reported 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: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 2,151 units · 102 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
10213,268
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 Alaska 13,268 /100k
2 New Mexico 102 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1000 tablets this page00904-7378-80 1,761 Rx · $43,096
500 tablets00904-7378-40 53 Rx · $347
Drug total (last 4 qtrs): 1,814 Rx · 102,245 units · $43,443 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00904-7378-40 500 TABLET in 1 BOTTLE (0904-7378-40) $0.0326 / ea $16.28 2023-08-01 Active
00904-7378-80 You're viewing this 1000 TABLET in 1 BOTTLE (0904-7378-80) $0.0326 / ea $32.55 2023-08-01 Active

You're viewing the largest of 2 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0326 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 97% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00904-7378-80?
NDC 00904-7378-80 is a 1,000-count package — 1000 tablet in 1 bottle.
What is the difference between NDC 00904-7378-80 and NDC 00904-7378-40?
Both are Hydroxyzine hydrochloride 25 mg Tablet — the drug itself is identical. NDC 00904-7378-80 is the 1,000-count package, while NDC 00904-7378-40 is the 500 tablets package.
What NDC number is used to bill for this package of Hydroxyzine hydrochloride 25 mg Tablet?
Bill NDC 00904-7378-80 — the 11-digit billing format is 00904737880. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 137 words ▾

ADVERSE REACTIONS Skin and Appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in post marketing reports. 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.

In post-marketing experience, the following additional undesirable effects have been reported: Cardiac System: QT prolongation, Torsade de Pointes. Body as a Whole: Allergic reaction. Nervous System : Headache.

Psychiatric : Hallucination. Skin and Appendages : 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 ~1 min read ▾

HOW SUPPLIED Hydroxyzine Hydrochloride Tablets, USP are available as follows: 10 mg tablets: round, film coated white tablets. Debossed H on one side and 500 on the reverse side. They are available as follows: Bottles of 500 film coated tablets, NDC 0904-7377-40 Bottles of 1000 film coated tablets, NDC 0904-7377-80 25 mg tablets: round, film coated white tablets.

Debossed H over 501 on one side and plain on the reverse side. They are available as follows: Bottles of 500 film coated tablets, NDC 0904-7378-40 Bottles of 1000 film coated tablets, NDC 0904-7378-80 50 mg tablets: round, film coated white tablets. Debossed H over 502 on one side and plain on the reverse side.

They are available as follows: Bottles of 500 film coated tablets, NDC 0904-7379-40 Bottles of 1000 film coated tablets, NDC 0904-7379-80 Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) 51U000000193US08 Rev. 09/2021 OR Manufactured by: Emcure Pharmaceuticals Ltd., Kadu, Surendranagar - 382775, India Manufactured for: Avet Pharmaceuticals Inc.

East Brunswick, NJ 08816 1.866.901.DRUG (3784) 510490427US01 Revised: 06/2023 Packaged and Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 USA Refer to package label for Distributor's NDC Number logo logo 1

📋 Description 80 words ▾

DESCRIPTION Hydroxyzine hydrochloride, USP has the chemical name of (±)-2-[2-[4-( p -Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. Molecular Formula: C 21 H 27 ClN 2 O 2 · 2HCl Molecular Weight: 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 anhydrous lactose, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate and titanium dioxide. stucture

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00904-7376-61 · Major 00904-7379-40 · 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.