Home › NDC Lookup › Ingredients › Hydroxyzine Hydrochloride › 00517-4201-25
Hydroxyzine Hydrochloride 25 mg/mL Injection, Solution, 25 vials — NDC 00517-4201-25 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hydroxyzine Hydrochloride 25 mg/mL Injection, Solution, 25 vials — NDC 0517-4201-25 (Billing 00517-4201-25)

by American Regent, Inc. · 25 VIAL, SINGLE-DOSE in 1 TRAY / 1 mL in 1 VIAL, SINGLE-DOSE

This is a package of 25 vials of Hydroxyzine Hydrochloride 25 mg/mL Injection, Solution from American Regent, Inc., marketed since Sep 1990 and currently FDA-listed. It is this product's only package size.

NDC 00517-4201-25
🏷️ FDA NDC (as labeled) 0517-4201-25 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 0517-4201-25 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0517 labeler · 4201 product · 25 package
Package marketed since
Sep 30, 1990
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0305174201254, 0305175601251, 0305175602258
Medicaid fills, this package
346 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0517-4201-25
Product NDC 0517-4201
11-digit billing NDC 00517420125
NCPDP billing unit ML — per mL (volume)
RxCUI 995270, 995285, 1794552, 1794554
UNII 76755771U3
UPC 0305174201254, 0305175601251, 0305175602258
Application # ANDA087408
SPL Set ID 8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a
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 1990-09-30
Route INTRAMUSCULAR
Dosage form INJECTION, SOLUTION
Substance HYDROXYZINE DIHYDROCHLORIDE

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

GPI-14 57200040102005
GPI class hydrOXYzine HCl
GCN Seq No 003723
GCN 13881
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 25 MG/ML VIAL
FDB brand name Hydroxyzine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 003723
  • GCN: 13881
  • GPI-14 (Medi-Span): 57200040102005
  • HICL (First Databank): 001608
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 995270
Why two NDCs? The FDA registers this code as 0517-4201-25 — 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 → 00517-4201-25. 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.

Clinical

Label name HYDROXYZINE 25 MG/ML VIAL Ingredient Hydroxyzine Hcl
📗 Our plain-language guide HelloPharmacist
  • Taken by mouth, it's used for anxiety and tension, itching from allergic skin conditions like hives and eczema, and sedation around anesthesia. The injection has additional uses in...
  • It can. Drowsiness is the most common effect, though it often fades in a few days or with a lower dose. Don't drive or use dangerous machinery until you know how it affects you.
  • It's best not to. Hydroxyzine can strengthen alcohol, narcotics, barbiturates and other sedating drugs. Tell your prescriber about everything you take, since doses of some may need...
  • Can I drink alcohol or take other sedating medicines with it?
📖 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.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $26.98 $674.45 / 25 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J3410 $15.209 / J3410 unit —
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)0517-4201-25
11-digit billing NDC00517-4201-25
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ3410
DescriptorINJECTION, HYDROXYZINE HCL, UP TO 25 MG
Billing units / pkg1 units
Medicare Part B spend (2026 (Q1))$391 · 20 claims · $19.57 per claim (all NDCs under J3410)
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00517-4201-25 You're viewing this Main listing 25 VIAL, SINGLE-DOSE in 1 TRAY / 1 mL in 1 VIAL, SINGLE-DOSE 1990-09-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydroxyzine Hydrochloride 25 mg/mLthis 00517-4201-25 American 25 vials — — FDA listed —
Hydroxyzine Hydrochloride 25 mg/mL 51662-1649-03 HF 25 pouches — — 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

🏛️
1990
On the market since
Sep 1990
📍
2026
Currently FDA-listed
36 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.

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.

Manufacturer & labeler

LabelerAmerican Regent, Inc.
Application holderAMERICAN REGENT INC
FDA applicationANDA087408 (ANDA)
Labeler code00517
First marketedSep 1990
Product typeHuman Prescription Drug
Portfolio72 products on file

More NDCs from American Regent, Inc. labeler code 00517

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 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE The total management of anxiety, tension, and psychomotor agitation in conditions of emotional stress requires in most instances a combined approach of psychotherapy and chemotherapy. Hydroxyzine has been found to be particularly useful for this latter phase of therapy in its ability to render the disturbed patient more amenable to psychotherapy in long term treatment of the psychoneurotic and psychotic, although it should not be used as the sole treatment of psychosis or of clearly demonstrated cases of depression.

Hydroxyzine is also useful in alleviating the manifestations of anxiety and tension as in the preparation for dental procedures and in acute emotional problems. It has also been recommended for the management of anxiety associated with organic disturbances and as adjunctive therapy in alcoholism and allergic conditions with strong emotional overlay, such as in asthma, chronic urticaria, and pruritus. Hydroxyzine hydrochloride intramuscular solution is useful in treating the following types of patients when intramuscular administration is indicated: 1.

The acutely disturbed or hysterical patient. 2. The acute or chronic alcoholic with anxiety withdrawal symptoms or delirium tremens.

3. As pre-and postoperative and pre- and postpartum adjunctive medication to permit reduction in narcotic dosage, allay anxiety and control emesis. Hydroxyzine hydrochloride has also demonstrated effectiveness in controlling nausea and vomiting, excluding nausea and vomiting of pregnancy.

(See CONTRAINDICATIONS ). In prepartum states, the reduction in narcotic requirement effected by hydroxyzine is of particular benefit to both mother and neonate. Hydroxyzine benefits the cardiac patient by its ability to allay the associated anxiety and apprehension attendant to certain types of heart disease.

Hydroxyzine is not known to interfere with the action of digitalis in any way and may be used concurrently with this agent. The effectiveness of hydroxyzine in 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 164 words ▾

DOSAGE AND ADMINISTRATION The recommended dosages for hydroxyzine hydrochloride intramuscular solution are: For adult psychiatric and emotional emergencies, including acute alcoholism. Intramuscular: 50 to100 mg stat., and every 4 to 6 hours as needed. Nausea and vomiting excluding nausea and vomiting of pregnancy.

Adults: 25 to 100 mg intramuscularly Children: 0.5 mg/lb body weight intramuscularly Pre- and postoperative adjunctive medication. Adults: 25 to 100 mg intramuscularly Children: 0.5 mg/lb body weight intramuscularly Pre- and postpartum adjunctive therapy. 25 to 100 mg intramuscularly As with all potent medications, the dosage should be adjusted according to the patient's response to therapy.

FOR ADDITIONAL INFORMATION ON THE ADMINISTRATION AND SITE OF SELECTION SEE PRECAUTIONS SECTION. NOTE: Hydroxyzine hydrochloride intramuscular solution may be administered without further dilution. Patients may be started on intramuscular therapy when indicated.

They should be maintained on oral therapy whenever this route is practicable. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

⛔ Contraindications 95 words ▾

CONTRAINDICATIONS Hydroxyzine hydrochloride intramuscular solution is intended only for intramuscular administration and should not, under any circumstances, be injected subcutaneously, intra-arterially or intravenously. Hydroxyzine is contraindicated in patients with a prolonged QT interval. This drug is contraindicated for patients who have shown a previous hypersensitivity to it.

Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit, induced fetal abnormalities in the rat 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.

⚠️ Warnings 29 words ▾

WARNINGS Tissue damage: Intramuscular hydroxyzine hydrochloride may result in severe injection site reactions (including extensive tissue damage, necrosis and gangrene) requiring surgical intervention (including debridement, skin grafting and amputation).

🤒 Adverse Reactions 151 words ▾

ADVERSE REACTIONS Therapeutic doses of hydroxyzine seldom produce impairment of mental alertness. However, drowsiness may occur; if so, it is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. Dryness of the mouth may be encountered at higher doses.

Extensive clinical use has substantiated the absence of toxic effects on the liver or bone marrow when administered in the recommended doses for over four years of uninterrupted therapy. The absence of adverse effects has been further demonstrated in experimental studies in which excessively high doses were administered. Involuntary motor activity, including rare instances of tremor and convulsions, has been reported, usually with doses considerably higher than those recommended.

Continuous therapy with over one gram per day has been employed in some patients without these effects having been encountered. Hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) in post marketing reports.

🧬 Clinical Pharmacology 190 words ▾

CLINICAL PHARMACOLOGY Hydroxyzine hydrochloride is unrelated chemically to phenothiazine, reserpine, and meprobamate. Hydroxyzine has demonstrated its clinical effectiveness in the chemotherapeutic aspect of the total management of neuroses and emotional disturbances manifested by anxiety, tension, agitation, apprehension or confusion. Hydroxyzine has been shown clinically to be a rapid-acting true ataraxic with a wide margin of safety.

It induces a calming effect in anxious, tense, psychoneurotic adults and also in anxious, hyperkinetic children without impairing mental alertness. It 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.

Hydroxyzine has been shown experimentally to have antispasmodic properties, apparently mediated through interference with the mechanism that responds to spasmogenic agents such as serotonin, acetylcholine, and histamine. Antihistaminic 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 provides mild antisecretory benefits.

📦 How Supplied / Storage and Handling 94 words ▾

HOW SUPPLIED Product No. Strength Size NDC-0517-4201-25 25 mg/mL 1 mL Single Dose Vial Boxes of 25 NDC-0517-5601-25 50 mg/mL 1 mL Single Dose Vial Boxes of 25 NDC-0517-5602-25 50 mg/mL 2 mL Single Dose Vial Boxes of 25 NDC-0517-5610-25 50 mg/mL 10 mL Multiple Dose Vial Boxes of 25 Storage Condition: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Protect from light.

Discard unused portion of the single dose vial. AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN4201 Rev.

10/16

📋 Description 71 words ▾

DESCRIPTION Hydroxyzine hydrochloride has the chemical name of (±)-2-[2-[4-( p -Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride and occurs as a white, odorless powder which is very soluble in water. It has the following structural formula: Hydroxyzine Hydrochloride Injection, USP is a sterile aqueous solution intended for intramuscular administration. Each mL contains: Hydroxyzine HCl 25 mg or 50 mg, Benzyl Alcohol 0.9%, and Water for Injection q.s. pH adjusted with Sodium Hydroxide and/or Hydrochloric Acid.

6e26bbb9-figure-01

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
346
Units reimbursed last 4 qtrs
904
Gross reimbursed last 4 qtrs
$24.4K
Avg / prescription
$70.49
Avg / unit
$26.9780
Latest quarter Q1 2026
22Rx
Fee-for-service vs managed care ⓘ
90% MCO
Fee-for-service · 36 Rx Managed care · 310 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 177 units · 4.2 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 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: 76 units · 1.7 per 100k residents 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: 58 units · 2.7 per 100k residents NM Kansas: 30 units · 1.0 per 100k residents KS Arkansas: no data reported AR Tennessee: 31 units · 0.4 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 41 units · 0.9 per 100k residents LA Mississippi: 15 units · 0.5 per 100k residents MS Alabama: 83 units · 1.6 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 327 units · 1.1 per 100k residents TX Florida: 66 units · 0.3 per 100k residents FL
Units reimbursed · per 100k residents
0.34.2
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 Oregon 4.2 /100k
2 New Mexico 2.7 /100k
3 Kentucky 1.7 /100k
4 Alabama 1.6 /100k
5 Texas 1.1 /100k
6 Kansas 1.0 /100k
7 Louisiana 0.9 /100k
8 Mississippi 0.5 /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
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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 ✓ 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

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 American Regent, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
American Regent, Inc. 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 J3410 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.
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.
← 00517-4002-25 · American 00517-4300-01 · American →
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.