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Bepotastine Besilate 15 mg/mL Solution/ Drops — NDC 24208-0630-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Bepotastine Besilate 15 mg/mL Solution/ Drops — NDC 24208-630-10 (Billing 24208-0630-10)

by Bausch & Lomb Incorporated · 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER

This is a package of Bepotastine Besilate 15 mg/mL Solution/ Drops from Bausch & Lomb Incorporated, marketed since May 2021 and currently FDA-listed; retail pharmacies pay about $8.29 per mL (NADAC).

NDC 24208-0630-10
🏷️ FDA NDC (as labeled) 24208-630-10 billing pads the product segment with a zero
This package
Contains10 mL in 1 bottle, dropper Cost per mL$8.29 NADAC Per package$82.86 / 10 ml Pack sizes2 compare ↓
Also priced by: Part D plans $21.36/unit — full pricing hub ↓
Product page 24208-0630-05 Also comes in: 5 mL 24208-630-05
Rx only Brand 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 24208-630-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
24208 labeler · 630 product · 10 package
Package marketed since
May 28, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 2420863010 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 24208-630-10
Product NDC 24208-630
11-digit billing NDC 24208063010
NCPDP billing unit ML — per mL (volume)
RxCUI 863038
UNII 6W18MO1QR3
Application # NDA022288
SPL Set ID 995f4fe0-d861-4137-8090-a8ffc71c46f4
Established class (EPC) Histamine-1 Receptor Antagonist
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-05-28
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance BEPOTASTINE BESILATE
TE code (Orange Book) AT · RLD · RS

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

GPI-14 86802008102020
GPI class Bepotastine Besilate
GCN Seq No 065598
GCN 27606
HICL code 036608
Ingredient (HICL) Bepotastine Besilate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6R
Therapeutic class — specific (HIC3) Eye Antihistamines
AHFS code 04:92.00.00
AHFS class Other Antihistamines
FDB label name BEPOTASTINE 1.5% EYE DROP
FDB brand name Bepotastine Besilate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 065598
  • GCN: 27606
  • GPI-14 (Medi-Span): 86802008102020
  • HICL (First Databank): 036608
  • AHFS class code: 04:92.00.00
  • RxCUI (RxNorm): 863038
Why two NDCs? The FDA registers this code as 24208-630-10 — 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 → 24208-0630-10. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
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 BEPOTASTINE 1.5% EYE DROP Ingredient Bepotastine Besilate
📗 Our plain-language guide HelloPharmacist
  • It treats itching of the eyes caused by allergic conjunctivitis. It is an antihistamine, so it blocks the histamine that causes the itch.
  • You put one drop in each affected eye, usually twice a day. Take your contact lenses out first. Follow your prescriber's directions and the label on your bottle.
  • Take your lenses out before putting the drops in. The preservative benzalkonium chloride can be absorbed by soft lenses. You can put them back in after 10 minutes. These drops shou...
  • The most common one is a mild taste in your mouth after the drop. Some people have eye irritation, headache or cold-like symptoms. These are generally mild.
📖 Read our full Bepotastine Ophthalmic 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 $8.286 $82.86 / 10 ml
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 · Q2 2026 $21.36 $213.63 / 10 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Dec 2023 Mar 2026 Sep 2026 $32.097 $8.286
▼ Down 74% over the last 17 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
24208-0630-05 24208-630-05 Main listing 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER $10.49 / mL $52.43 2021-05-28 — Active
24208-0630-10 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER $8.29 / mL $82.86 2021-05-28 — Active

This pack has the lowest per-mL cost of the 2 priced pack sizes ($8.29 NADAC).

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Bepotastine Besilate 15 mg/mL Solution/ Drops?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bepotastine Besilate 15 mg/mLthis 24208-0630-10 Bausch 1 bottle $8.286 AT Availability likely —
Bepotastine Besilate 15 mg/mL 70069-0712-01 Somerset 1 bottle $8.286 AT Availability likely —
Bepotastine Besilate 15 mg/mL 00378-7055-35 Mylan 1 bottle $10.487 AT Availability likely +27%
Bepotastine Besilate Ophthalmic Solution 1.5% 15 mg/mL 62332-0598-05 Alembic 1 bottle $10.487 AT Availability likely +27%
Bepotastine Besilate 15 mg/mL 70069-0711-01 Somerset 1 bottle $10.487 AT Availability likely +27%
Bepotastine Besilate 15 mg/mL 82260-0630-05 Bausch 1 bottle $10.487 AT Availability likely +27%
Bepreve 15 mg/mL 24208-0629-01 Bausch 1 bottle $53.811 AT FDA listed +549%
Bepotastine Besilate Ophthalmic Solution 1.5% 15 mg/mL 46708-0598-05 Alembic 1 bottle — AT FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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

🏛️
2021
On the market since
May 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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

LabelerBausch & Lomb Incorporated
Application holderBAUSCH AND LOMB INC
FDA applicationNDA022288 (NDA AUTHORIZED GENERIC)
Labeler code24208
First marketedMay 2021
Product typeHuman Prescription Drug
Portfolio92 products on file

More NDCs from Bausch & Lomb Incorporated labeler code 24208

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 54 words ▾

1 INDICATIONS AND USAGE Bepotastine Besilate Ophthalmic Solution, 1.5% is a histamine H 1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. Bepotastine Besilate Ophthalmic Solution is a histamine H 1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis. ( 1 )

⏱️ Dosage and Administration 57 words ▾

2 DOSAGE AND ADMINISTRATION Instill one drop of Bepotastine Besilate Ophthalmic Solution into the affected eye(s) twice a day. Remove contact lenses prior to instillation of Bepotastine Besilate Ophthalmic Solution. Instill one drop into the affected eye(s) twice a day. ( 2 ) Remove contact lenses prior to instillation of Bepotastine Besilate Ophthalmic Solution. ( 2 )

💊 Dosage Forms and Strengths 24 words ▾

3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution containing bepotastine besilate 15 mg/mL (1.5%). Ophthalmic solution containing bepotastine besilate, 15 mg/mL (1.5%). ( 3 )

⛔ Contraindications 41 words ▾

4 CONTRAINDICATIONS Bepotastine Besilate Ophthalmic Solution is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients [see Adverse Reactions ( 6.2 )] . Hypersensitivity to any component of this product. ( 4 )

⚠️ Warnings and Cautions 157 words ▾

5 WARNINGS AND PRECAUTIONS • Contamination of Solution: Do not touch the dropper tip to any surface. Keep bottle tightly closed when not in use. ( 5.1 ) • Contact Lens Wear: Bepotastine Besilate Ophthalmic Solution should not be used to treat contact lens-related irritation. ( 5.2 )

5.1Contamination of Tip and Solution To minimize contaminating the dropper tip and solution, advise the patient not to touch the eyelids or surrounding areas with the dropper tip of the bottle and to keep the bottle tightly closed when not in use.

5.2Contact Lens Wear Bepotastine Besilate Ophthalmic Solution should not be used to treat contact lens-related irritation. Bepotastine Besilate Ophthalmic Solution should not be instilled while wearing contact lenses. Patient should remove contact lenses prior to instillation of Bepotastine Besilate Ophthalmic Solution, because benzalkonium chloride may be absorbed by soft contact lenses.

Lenses may be reinserted after 10 minutes following administration of Bepotastine Besilate Ophthalmic Solution.

🤒 Adverse Reactions 198 words ▾

6 ADVERSE REACTIONS The most common adverse reaction occurring in approximately 25% of patients was a mild taste following instillation. Other adverse reactions which occurred in 2-5% of subjects were eye irritation, headache, and nasopharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1‑800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The most common reported adverse reaction occurring in approximately 25% of subjects was a mild taste following instillation. Other adverse reactions occurring in 2-5% of subjects were eye irritation, headache, and nasopharyngitis.

6.2Post-Marketing Experience Hypersensitivity reactions have been reported rarely during the post-marketing use of Bepotastine Besilate Ophthalmic Solution. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The hypersensitivity reactions may include itching, body rash, and swelling of lips, tongue and/or throat.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available human data for the use of Bepotastine Besilate Ophthalmic Solution during pregnancy to inform any drug-associated risks. Oral administration of bepotastine besilate to pregnant rats or rabbits during organogenesis or during the pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures. Maternal toxicity was observed in the rabbits at the lowest dose administered, 20 mg/kg/day (215 times the maximum recommended human ophthalmic dose, RHOD, on a mg/m 2 basis) [ see Data ] .

The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. Data Animal Data In embryofetal development studies, oral administration of bepotastine besilate to pregnant rabbits throughout organogenesis did not produce teratogenic effects at maternal doses up to 500 mg/kg/day (approximately 5400 times the maximum RHOD, on a mg/m 2 basis).

A maternal no observed adverse effect level (NOAEL) was not identified in this study due to spontaneous abortion observed at the lowest dose tested, 20 mg/kg/day (approximately 215 times higher than the maximum RHOD, on a mg/m 2 basis). Oral administration of bepotastine besilate to pregnant rats throughout organogenesis produced skeletal anomalies at 1000 mg/kg/day (5400 times higher than the maximum RHOD, on a mg/m 2 basis), a dose that also produced maternal toxicity and lethality. No teratogenic effects were observed in rats at maternal doses up to 200 mg/kg/day (corresponding to an estimated blood plasma concentration 3300 times higher than that anticipated in humans at the maximum RHOD).

A maternal NOAEL was observed at 10 mg/kg/day (54 times higher than the maximum RHOD, on a mg/m 2 basis). Following a single 3 mg/kg oral dose in rats (16 times higher than the maximum RHOD, on a mg/m 2 basis), the concentration of radio-labeled bepotastine besilate was similar in fetal liver and maternal blood plasma. The concentration in other fetal tissues was one-third to one-tenth the concentration in maternal blood plasma.

In a pre/postnatal development study, oral administration of bepotastine besilate to rats during the perinatal and lactation periods produced an increase in stillbirths and decreased growth and development in offspring at a maternal dose of 1000 mg/kg/day (5400 times higher than the maximum RHOD, on a mg/m 2 basis). There were no observed adverse effects on offspring of rats treated with 100 mg/kg/day (540 times higher than the maximum RHOD, on a mg/m 2 basis). Effects on parturition and maternal lethality were observed at 100 mg/kg/day and 1000 mg/kg/day, respectively.

A maternal NOAEL was observed at 10 mg/kg/day (54 times higher than the maximum RHOD, on a mg/m 2 basis).

8.2Lactation Risk Summary There are no data on the presence of Bepotastine Besilate Ophthalmic Solution in human milk, the effects on the breastfed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for Bepotastine Besilate Ophthalmic Solution, and any potential adverse effects on the breastfed infant from Bepotastine Besilate Ophthalmic Solution. Animal Data Following a single 3 mg/kg oral dose (16 times the maximum RHOD, on a mg/m 2 basis) of radiolabeled bepotastine besilate to nursing rats 11 days after delivery, the maximum concentration of radioactivity in milk was 0.40 mcg-eq/mL 1 hour after administration; at 48 hours after administration, the radioactivity concentration was below detection limits.

The milk radioactivity concentration was higher than the maternal blood plasma radioactivity concentration at each time of measurement. It is not known whether bepotastine besilate would be pre… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no available human data for the use of Bepotastine Besilate Ophthalmic Solution during pregnancy to inform any drug-associated risks. Oral administration of bepotastine besilate to pregnant rats or rabbits during organogenesis or during the pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures. Maternal toxicity was observed in the rabbits at the lowest dose administered, 20 mg/kg/day (215 times the maximum recommended human ophthalmic dose, RHOD, on a mg/m 2 basis) [ see Data ] .

The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. Data Animal Data In embryofetal development studies, oral administration of bepotastine besilate to pregnant rabbits throughout organogenesis did not produce teratogenic effects at maternal doses up to 500 mg/kg/day (approximately 5400 times the maximum RHOD, on a mg/m 2 basis).

A maternal no observed adverse effect level (NOAEL) was not identified in this study due to spontaneous abortion observed at the lowest dose tested, 20 mg/kg/day (approximately 215 times higher than the maximum RHOD, on a mg/m 2 basis). Oral administration of bepotastine besilate to pregnant rats throughout organogenesis produced skeletal anomalies at 1000 mg/kg/day (5400 times higher than the maximum RHOD, on a mg/m 2 basis), a dose that also produced maternal toxicity and lethality. No teratogenic effects were observed in rats at maternal doses up to 200 mg/kg/day (corresponding to an estimated blood plasma concentration 3300 times higher than that anticipated in humans at the maximum RHOD).

A maternal NOAEL was observed at 10 mg/kg/day (54 times higher than the maximum RHOD, on a mg/m 2 basis). Following a single 3 mg/kg oral dose in rats (16 times higher than the maximum RHOD, on a mg/m 2 basis), the concentration of radio-labeled bepotastine besilate was similar in fetal liver and maternal blood plasma. The concentration in other fetal tissues was one-third to one-tenth the concentration in maternal blood plasma.

In a pre/postnatal development study, oral administration of bepotastine besilate to rats during the perinatal and lactation periods produced an increase in stillbirths and decreased growth and development in offspring at a maternal dose of 1000 mg/kg/day (5400 times higher than the maximum RHOD, on a mg/m 2 basis). There were no observed adverse effects on offspring of rats treated with 100 mg/kg/day (540 times higher than the maximum RHOD, on a mg/m 2 basis). Effects on parturition and maternal lethality were observed at 100 mg/kg/day and 1000 mg/kg/day, respectively.

A maternal NOAEL was observed at 10 mg/kg/day (54 times higher than the maximum RHOD, on a mg/m 2 basis).

🧒 Pediatric Use 51 words ▾

8.4Pediatric Use Safety and efficacy of Bepotastine Besilate Ophthalmic Solution, 1.5% have not been established in pediatric patients under 2 years of age. Efficacy in pediatric patients under 10 years of age was extrapolated from clinical trials conducted in pediatric patients greater than 10 years of age and from adults.

🧓 Geriatric Use 18 words ▾

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Bepotastine is a topically active, direct H 1 -receptor antagonist and an inhibitor of the release of histamine from mast cells.

12.3Pharmacokinetics Absorption : The extent of systemic exposure to bepotastine following topical ophthalmic administration of bepotastine besilate 1% and 1.5% ophthalmic solutions was evaluated in 12 healthy adults. Following one drop of 1% or 1.5% bepotastine besilate ophthalmic solution to both eyes four times daily (QID) for 7 days, bepotastine plasma concentrations peaked at approximately 1 to 2 hours post-instillation. Maximum plasma concentrations for the 1% and 1.5% strengths were 5.1 ± 2.5 ng/mL and 7.3 ± 1.9 ng/mL, respectively.

Plasma concentrations at 24 hours post-instillation were below the quantifiable limit (2 ng/mL) in 11/12 subjects in the two dose groups. Distribution : The extent of protein binding of bepotastine is approximately 55% and independent of bepotastine concentration. Metabolism : In vitro metabolism studies with human liver microsomes demonstrated that bepotastine is minimally metabolized by CYP450 isozymes.

In vitro studies demonstrated that bepotastine besilate does not inhibit the metabolism of various cytochrome P450 substrates via inhibition of CYP3A4, CYP2C9, and CYP2C19. The effect of bepotastine besilate on the metabolism of substrates of CYP1A2, CYP2C8 and CYP2D6 was not studied. Bepotastine besilate has a low potential for drug interaction via inhibition of CYP3A4, CYP2C9, and CYP2C19.

Excretion : The main route of elimination of bepotastine besilate is urinary excretion (with approximately 75-90% excreted unchanged in urine).

🧬 Mechanism of Action 25 words ▾

12.1Mechanism of Action Bepotastine is a topically active, direct H 1 -receptor antagonist and an inhibitor of the release of histamine from mast cells.

📦 How Supplied / Storage and Handling 58 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Bepotastine Besilate Ophthalmic Solution, 1.5% is supplied in a white low density polyethylene bottle with a sterile linear low density polyethylene controlled dropper tip and a white polyproplyene cap in the following sizes: NDC 24208-630-05 5 mL Bottle NDC 24208-630-10 10 mL Bottle Storage: Store at 15° to 25°C (59° to 77°F) .

📋 Description 142 words ▾

11 DESCRIPTION Bepotastine Besilate Ophthalmic Solution, 1.5% is a sterile, topically administered drug for ophthalmic use. Each mL of Bepotastine Besilate Ophthalmic Solution contains 15 mg bepotastine besilate. Bepotastine besilate is designated chemically as (+) -4-[[(S)-p-chloro-alpha -2-pyridylbenzyl]oxy]-1-piperidine butyric acid monobenzenesulfonate.

The chemical structure for bepotastine besilate is: Bepotastine besilate is a white to pale yellowish-white crystalline powder. The molecular weight of bepotastine besilate is 547.06 daltons. Bepotastine Besilate Ophthalmic Solution is supplied as a sterile, aqueous 1.5% solution, with an approximate pH of 6.8.

The osmolality of Bepotastine Besilate Ophthalmic Solution, 1.5% is approximately 295 mOsm/kg. Each mL of Bepotastine Besilate Ophthalmic Solution, 1.5% contains: • Active: bepotastine besilate 15 mg (equivalent to 10.7 mg bepotastine) • Inactives: monobasic sodium phosphate dihydrate, sodium chloride, sodium hydroxide to adjust pH, and water for injection, USP. • Preservative: benzalkonium chloride 0.005% Bepreve chemical structure

💬 Information for Patients 152 words ▾

17 PATIENT COUNSELING INFORMATION • Sterility of Dropper Tip Advise patients not to touch the dropper tip to any surface, as this may contaminate the solution and to keep the bottle tightly closed when not in use. • Concomitant Use of Contact Lenses Advise patients not to wear a contact lens if their eye is red and that Bepotastine Besilate Ophthalmic Solution should not be used to treat contact lens-related irritation. Patients should also be advised to remove contact lenses prior to instillation of Bepotastine Besilate Ophthalmic Solution, which may be reinserted after 10 minutes following administration.

Distributed by: Bausch + Lomb, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA Under license from: Senju Pharmaceutical Co., Ltd. Osaka, Japan 541-0046 U.S. Patent Numbers: 8,784,789 and 8,877,168 © 2020 Bausch & Lomb Incorporated or its affiliates 9751300 (folded) 9751400 (flat)

🧬 Pharmacokinetics 216 words ▾

12.3Pharmacokinetics Absorption : The extent of systemic exposure to bepotastine following topical ophthalmic administration of bepotastine besilate 1% and 1.5% ophthalmic solutions was evaluated in 12 healthy adults. Following one drop of 1% or 1.5% bepotastine besilate ophthalmic solution to both eyes four times daily (QID) for 7 days, bepotastine plasma concentrations peaked at approximately 1 to 2 hours post-instillation. Maximum plasma concentrations for the 1% and 1.5% strengths were 5.1 ± 2.5 ng/mL and 7.3 ± 1.9 ng/mL, respectively.

Plasma concentrations at 24 hours post-instillation were below the quantifiable limit (2 ng/mL) in 11/12 subjects in the two dose groups. Distribution : The extent of protein binding of bepotastine is approximately 55% and independent of bepotastine concentration. Metabolism : In vitro metabolism studies with human liver microsomes demonstrated that bepotastine is minimally metabolized by CYP450 isozymes.

In vitro studies demonstrated that bepotastine besilate does not inhibit the metabolism of various cytochrome P450 substrates via inhibition of CYP3A4, CYP2C9, and CYP2C19. The effect of bepotastine besilate on the metabolism of substrates of CYP1A2, CYP2C8 and CYP2D6 was not studied. Bepotastine besilate has a low potential for drug interaction via inhibition of CYP3A4, CYP2C9, and CYP2C19.

Excretion : The main route of elimination of bepotastine besilate is urinary excretion (with approximately 75-90% excreted unchanged in urine).

🔬 Clinical Studies 78 words ▾

14 CLINICAL STUDIES Clinical efficacy was evaluated in two conjunctival allergen challenge (CAC) studies (237 patients). Bepotastine Besilate Ophthalmic Solution, 1.5% was more effective than its vehicle for relieving ocular itching induced by an ocular allergen challenge, both at a CAC 15 minutes post-dosing and a CAC 8 hours post-dosing of Bepotastine Besilate Ophthalmic Solution. The safety of Bepotastine Besilate Ophthalmic Solution was evaluated in a randomized clinical study of 861 subjects over a period of 6 weeks.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term dietary studies in mice and rats were conducted to evaluate the carcinogenic potential of bepotastine besilate. Bepotastine besilate did not significantly induce neoplasms in mice receiving a nominal dose of up to 200 mg/kg/day for 21 months, or in rats receiving a nominal dose of up to 97 mg/kg/day for 24 months. These dose levels correspond to systemic exposures approximately 350 and 200 times higher than that achieved at the RHOD, respectively.

The no observable adverse effect level for bepotastine besilate based on nominal dose levels in carcinogenicity tests were 18.7 to 19.9 mg/kg/day in mice and 9.6 to 9.8 mg/kg/day in rats (corresponding to systemic exposures approximately 60 and 20 times higher than that anticipated in humans at RHOD, respectively). Mutagenesis There was no evidence of genotoxicity in the Ames test (mutagenicity), in CHO cells (chromosome aberration), in mouse hepatocytes (unscheduled DNA synthesis), or in the mouse micronucleus test.

Impairment of Fertility Oral administration of bepotastine to male and female rats at doses up to 1000 mg/kg/day (5400 times higher than the maximum RHOD, on a mg/m 2 basis) resulted in reduction in fertility index and surviving fetuses. Oral administration of bepotastine besilate produced no observed adverse effects on fertility or reproduction in rats at oral doses up to 200 mg/kg/day (corresponding to an estimated blood plasma concentration 3300 times higher than that anticipated in humans at the RHOD).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term dietary studies in mice and rats were conducted to evaluate the carcinogenic potential of bepotastine besilate. Bepotastine besilate did not significantly induce neoplasms in mice receiving a nominal dose of up to 200 mg/kg/day for 21 months, or in rats receiving a nominal dose of up to 97 mg/kg/day for 24 months. These dose levels correspond to systemic exposures approximately 350 and 200 times higher than that achieved at the RHOD, respectively.

The no observable adverse effect level for bepotastine besilate based on nominal dose levels in carcinogenicity tests were 18.7 to 19.9 mg/kg/day in mice and 9.6 to 9.8 mg/kg/day in rats (corresponding to systemic exposures approximately 60 and 20 times higher than that anticipated in humans at RHOD, respectively). Mutagenesis There was no evidence of genotoxicity in the Ames test (mutagenicity), in CHO cells (chromosome aberration), in mouse hepatocytes (unscheduled DNA synthesis), or in the mouse micronucleus test.

Impairment of Fertility Oral administration of bepotastine to male and female rats at doses up to 1000 mg/kg/day (5400 times higher than the maximum RHOD, on a mg/m 2 basis) resulted in reduction in fertility index and surviving fetuses. Oral administration of bepotastine besilate produced no observed adverse effects on fertility or reproduction in rats at oral doses up to 200 mg/kg/day (corresponding to an estimated blood plasma concentration 3300 times higher than that anticipated in humans at the RHOD).

📄 Package Label / Principal Display Panel 24 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 24208-630-05 Bepotastine Besilate Ophthalmic Solution, 1.5% Sterile FOR TOPICAL OPHTHALMIC USE Rx only 5 mL BAUSCH + LOMB carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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.
1 bottle24208-0630-05 76 Rx · $6,999
1 bottle this page24208-0630-10 No Medicaid data
Drug total (last 4 qtrs): 76 Rx · 420 units · $6,999 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Bepotastine Besilate — the program that covers self-administered drugs. 4 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Bepotastine Besilate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.11M
Claims incl. refills
17.3K
Beneficiaries
9.2K
Spend / beneficiary
$229.56
Spend / claim
$121.82
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 24208-0629-01 · Bausch 24208-0631-10 · Bausch →
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.