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diphenhydramine hydrochloride 25 mg Tablet, Film Coated, 62,261-count

by Janssen Cilag SpA · 62261 TABLET, FILM COATED in 1 DRUM (62579-226-00)
NDC 62579-0226-00
🏷️ FDA NDC (as labeled) 62579-226-00 billing pads the product segment with a zero
On market Non-controlled
🗂️ 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

🆔 Identity & classification

FDA NDC (as labeled) 62579-226-00
Product NDC 62579-226
11-digit billing NDC 62579022600
SPL Set ID 47f6ea8f-056c-3516-e063-6294a90a7329
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-05-01
Dosage form TABLET, FILM COATED
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 62579-226-00 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 62579-0226-00. 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.

🏭 Manufacturer & labeler

LabelerJanssen Cilag SpA
Labeler code62579
First marketedMay 2012
Product typeDrug For Further Processing
Portfolio11 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

📗 Our plain-language guide HelloPharmacist
  • Diphenhydramine is mainly used to temporarily ease the stuffy, sneezy, itchy symptoms of allergies — like hay fever — and the common cold. Think runny nose, sneezing, watery or itc...
  • What exactly does diphenhydramine treat?
  • Yes, and that's one of the most important things to know about this medicine. Drowsiness is one of its most common effects — it crosses into the brain and that's what causes the se...
  • It depends on your child's age and the product. Most oral diphenhydramine products are not recommended for children under 6, and liquid products labeled for children are generally...
📖 Read our full Diphenhydramine 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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Diphenhydramine Hydrochloride 25 mg 68094-0018-61 Precision 100 tablets $0.037 — Availability likely —
good sense allergy relief 25 mg 00113-0479-62 L. 24 tablets $0.037 — Availability likely —
Allergy Relief 25 mg 83324-0088-01 CHAIN 100 tablets $0.037 — Availability likely —
Allergy Relief 25 mg 49483-0061-01 TIME 100 tablets $0.037 — Availability likely —
Allergy Relief 25 mg 70677-1238-01 Strategic 120 tablets $0.037 — Availability likely —
Nighttime Sleep Aid 25 mg 83324-0110-32 CHAIN 32 tablets $0.060 — Availability likely —
Rest Simply 25 mg 83324-0113-01 CHAIN 100 tablets $0.060 — Availability likely —
good sense nighttime sleep aid 25 mg 00113-0431-62 L. 2 tablets $0.060 — Availability likely —
Nighttime Sleep Aid 25 mg 63868-0611-32 Chain 32 tablets $0.066 — FDA listed —
Diphenhydramine Hydrochloride 25 mg 17714-0135-01 Advance 100 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 49483-0329-00 Time-Cap 100000 tablets — — FDA listed —
Sleep Aid 25 mg 76168-0015-07 Velocity 36 tablets — — FDA listed —
Allergy 25 mg 76168-0121-12 Velocity 100 tablets — — FDA listed —
Allergy Relief 25 mg 61504-0090-03 AMERIFOODS 100 tablets — — FDA listed —
Circle K Allergy Antihistamine 25 mg 66715-5554-02 Lil' 2 tablets — — Discontinued —
Benadryl Allergy Ultratab 25 mg 67414-0226-00 Jones 2 tablets — — FDA listed —
Benadryl 25 mg 71205-0521-06 Proficient 2 tablets — — FDA listed —
diphenhydramine hydrochloride 25 mg 76457-0002-00 Simpex 100 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 68210-1020-00 Prodose, 100000 tablets — — FDA listed —
Allergy Relief 25 mg 36800-0909-01 TopCo 12 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 37808-0019-02 HEB 32 tablets — — FDA listed —
careone nighttime sleep aid 25 mg 41520-0431-62 American 2 tablets — — FDA listed —
Benadryl Ultra Tab 25 mg 50269-0226-54 JC 25 tablets — — FDA listed —
Simply Sleep 25 mg 50580-0843-12 Kenvue 100 tablets — — FDA listed —
Rest Simply 25 mg 53943-0191-01 DISCOUNT 6 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 63941-0219-01 VALU 16 tablets — — FDA listed —
Benadryl 25 mg 66715-6406-02 Lil' 2 tablets — — FDA listed —
Allergy Relief 25 mg 00363-9024-60 Walgreens 600 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 69842-0834-51 CVS 365 tablets — — FDA listed —
GOOD REMEDIES Nighttime Sleep Aid Caplets 25 mg 70692-0011-06 Strive 60 tablets — — FDA listed —
Somnitabs 25 mg 72036-0019-02 HARRIS 32 tablets — — FDA listed —
Rest Simply 25 mg 72036-0091-01 Harris 12 tablets — — FDA listed —
Allergy Relief 25 mg 82725-1001-01 Cabinet 600 tablets — — FDA listed —
Goodmeds Allergy Relief Diphenhydramine HCl 25 mg 82725-4101-01 Cabinet 600 tablets — — FDA listed —
Good Neighbor Pharmacy allergy 25 mg 24385-0479-62 Amerisource 24 tablets — — Discontinued —
topcare sleep aid nighttime 25 mg 36800-0431-62 Topco 2 tablets — — FDA listed —
nighttime sleep aid 25 mg 37808-0431-62 H 2 tablets — — FDA listed —
CAREALL Diphenhydramine 25 mg 51824-0056-01 New 100 tablets — — FDA listed —
Benadryl 25 mg 53209-3001-02 Morning 2 tablets — — FDA listed —
Allergy Relief 25 mg 00363-0100-61 WALGREENS 600 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 70692-0151-46 Strive 72 tablets — — FDA listed —
Medique Diphen 25 mg 47682-0167-46 Unifirst 1 tablet — — FDA listed —
Nyt Time Sleep Caps 25 mg 53943-0128-03 DISCOUNT 72 tablets — — FDA listed —
Rest Simply 25 mg 63868-0772-10 Chain 100 tablets — — FDA listed —
Sominex 25 mg 67751-0221-01 Navajo 8 tablets — — FDA listed —
Rest Simply 25 mg 68998-0091-01 Marc 12 tablets — — FDA listed —
GOOD REMEDIES Allergy Relief 25 mg 70692-0022-06 Strive 60 tablets — — FDA listed —
Allergy Relief 25 mg 71679-0106-06 Health 600 tablets — — FDA listed —
Allergy Relief 25 mg 72036-0090-01 Harris 12 tablets — — FDA listed —
AXIV Allergy Relief 25 mg 82706-0021-02 VIVUNT 100 tablets — — FDA listed —
Allergy Relief 25 mg 37808-0590-02 HEB 12 tablets — — FDA listed —
Allergy Relief 25 mg 42507-0290-01 HYVEE 12 tablets — — FDA listed —
CVS Diphenhydramine Hydrochloride 25 mg 51316-0191-00 CVS 365 tablets — — FDA listed —
Allergy Relief 25 mg 55681-0323-03 TWIN 300 tablets — — FDA listed —
Allergy Relief 25 mg 55910-0959-24 DOLGENCORP, 24 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 57344-0091-03 AAA 100 tablets — — FDA listed —
Benadryl Allergy Ultratab 25 mg 73097-0004-02 Savings 2 tablets — — FDA listed —
equate allergy relief 25 mg 79903-0297-10 WALMART 100 tablets — — FDA listed —
Betr sleep aid 25 mg 80267-0431-67 Live 2 tablets — — FDA listed —
ValuMeds Allergy Relief Antihistamine Diphenhydramine HCl 25 mg 82725-1101-01 Cabinet 600 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 68210-1016-00 Prodose, 100000 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 37835-0641-01 Bi-Mart 100 tablets — — FDA listed —
allergy 25 mg 41250-0479-53 Meijer 12 tablets — — Discontinued —
Rest Simply 25 mg 42507-0291-03 HYVEE 100 tablets — — FDA listed —
diphenhydramine hydrochloride 25 mg 51662-1674-01 HF 1 tablet — — FDA listed —
Benadryl Ultratabs 25 mg 67751-0166-01 Navajo 2 tablets — — FDA listed —
meijer Allergy Relief 25 mg 79481-0148-04 Meijer, 24 tablets — — FDA listed —
Dormmy-Lon 25 mg 83164-0000-01 Haendel 60 tablets — — FDA listed —
Diphenhydramine hydrochloride 25 mg 14803-0273-00 Elysium 100000 tablets — — FDA listed —
Diphenhydramine hydrochloride 25 mg 50580-0001-01 Kenvue 120000 tablets — — FDA listed —
Allergy 25 mg 41226-0160-01 Kroger 100 tablets — — FDA listed —
CVS Diphenhydramine Hydrochloride 25 mg 51316-0186-25 CVS 365 tablets — — FDA listed —
allergy 25 mg 56062-0479-62 Publix 24 tablets — — Discontinued —
welby allergy relief 25 mg 64024-0479-78 Aldi 100 tablets — — FDA listed —
Allergy Relief 25 mg 68391-0160-33 BJWC 600 tablets — — FDA listed —
Cabinet Allergy Relief Refill Diphenhydramine HCI 25 mg 82725-3001-02 Cabinet 120 tablets — — FDA listed —
Allergy Relief 25 mg 83059-0021-03 Shield 36 tablets — — FDA listed —
careone allergy relief 25 mg 41520-0778-62 American 24 tablets — — Discontinued —
Benadryl 25 mg 50580-0226-50 Kenvue 100 tablets — — FDA listed —
CAREALL Allergy Relief 25 mg 51824-0102-01 New 100 tablets — — FDA listed —
dg health sleep aid 25 mg 55910-0431-62 Dolgencorp 2 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 56062-0091-01 PUBLIX 6 tablets — — FDA listed —
Diphenhydramine 25 mg 57344-0090-02 AAA 12 tablets — — FDA listed —
Allergy Relief 25 mg 63941-0090-01 VALU 12 tablets — — FDA listed —
Benadryl 25 mg 66715-9706-02 Lil' 2 tablets — — FDA listed —
Benadryl Allergy 25 mg 70264-0024-01 R 2 tablets — — FDA listed —
Allergy Relief 25 mg 79903-0056-10 Wal-Mart 100 tablets — — FDA listed —
Goodmeds Allergy Relief 25 mg 82725-4201-01 Cabinet 600 tablets — — FDA listed —
Allergy Relief Caplet 25 mg 36800-0937-40 TOPCO 400 tablets — — FDA listed —
Allergy 25 mg 53943-0090-01 Discount 12 tablets — — FDA listed —
Nighttime SleepAid 25 mg 61504-0091-03 AMERIFOODS 100 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 63941-0091-01 VALU 6 tablets — — FDA listed —
Benadryl 25 mg 66715-6506-02 Lil' 2 tablets — — FDA listed —
Berkley and Jensen Allergy Relief 25 mg 68391-0200-79 BJWC 400 tablets — — FDA listed —
basic care allergy relief 25 mg 72288-0479-78 Amazon.com 100 tablets — — FDA listed —
equate nighttime sleep aid 25 mg 79903-0274-36 WALMART 365 tablets — — FDA listed —
Allergy Relief 25 mg 81522-0109-03 FSA 100 tablets — — FDA listed —
PhysiciansCare Allergy Antihistamine 25 mg 00924-0056-01 Acme 1 tablet — — FDA listed —
Allergy Relief 25 mg 41163-0290-03 United 100 tablets — — FDA listed —
Allergy Relief 25 mg 41520-0290-11 FOODHOLD 300 tablets — — FDA listed —
Benadryl Allergy 25 mg 50269-0528-00 JC 20 tablets — — FDA listed —
Allergy Relief 25 mg 53942-0190-05 Demoulas 400 tablets — — FDA listed —
DG Health Allergy 25 mg 55910-0479-78 Dolgencorp 100 tablets — — Discontinued —
Kroger Nighttime Sleep Aid CAPLET 25 mg 59450-0601-01 The 100 tablets — — FDA listed —
Allergy Relief 25 mg 63868-0492-10 Chain 100 tablets — — FDA listed —
Allergy Relief 25 mg 68196-0160-60 SAM'S 600 tablets — — FDA listed —
meijer NIGHTTIME Sleep Aid CAPLET 25 mg 79481-0151-01 Meijer, 100 tablets — — FDA listed —
Goodmeds Allergy Relief Diphenhydramine HCl 25 mg 82725-4001-01 Cabinet 600 tablets — — FDA listed —
Diphenhydramine hydrochloride 25 mg 50580-0002-01 Kenvue 120000 tablets — — FDA listed —
diphenhydramine hydrochloride 25 mgthis 62579-0226-00 Janssen 62261 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 83059-0004-00 Shield 10000 tablets — — FDA listed —
Sominex 25 mg 63029-0554-01 Medtech 8 tablets — — FDA listed —
Allergy Relief 25 mg 68998-0090-03 Marc 100 tablets — — FDA listed —
Allergy Relief 25 mg 00363-9023-36 Walgreens 365 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 69842-0981-08 CVS 200 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 71679-0308-00 Health 100000 tablets — — FDA listed —
Benadryl 25 mg 85237-1960-01 Select 2 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 71679-0311-00 Health 100000 tablets — — FDA listed —
DG Health Allergy Relief 25 mg 55910-0923-78 Dolgencorp 100 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 87550-0002-01 EFDEE 50000 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 55154-1589-00 Cardinal 10 tablets — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 87550-0006-01 EFDEE 50000 tablets — — FDA listed —
Allergy Relief 25 mg 72288-0391-01 Amazon.com 400 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2012
On the market since
May 2012
📍
2026
Currently FDA-listed
14 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for DIPHENHYDRAMINE HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Fatigue16,399
Nausea14,606
Headache14,003
Pain11,969
Dyspnoea11,085
Pruritus10,525
Infusion Related Reaction9,947

Age at onset

Neonate106
Infant195
Child1,828
Adolescent1,476
Adult20,867
Elderly9,044

Reporter sex

171,992 reports
Male · 33%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization49,087
Life-threatening7,190
Disabling3,673
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 13,771 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
62579-0226-00 You're viewing this 62261 TABLET, FILM COATED in 1 DRUM (62579-226-00) — Active

🧭 About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Janssen Cilag SpA supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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 — Not published for this NDC No photo available yet for this listing.
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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
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 FDA registers it as 62579-226-00, 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: 62579-0226-00, written without dashes as 62579022600. 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 62579-0226-00, the first segment (62579) is the labeler code FDA assigned to Janssen Cilag SpA; the middle segment (0226) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Janssen Cilag SpA. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Janssen Cilag SpA 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.
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.

📄 Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 62569-0981-02 · Genlabs 62579-0301-00 · Janssen →
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.