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Difluprednate .5 mg/mL Emulsion — NDC 65145-0161-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Difluprednate .5 mg/mL Emulsion — NDC 65145-161-01 (Billing 65145-0161-01)

by Caplin Steriles Limited · 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE

This is a package of Difluprednate .5 mg/mL Emulsion from Caplin Steriles Limited, marketed since Dec 2024 and currently FDA-listed; retail pharmacies pay about $9.69 per mL (NADAC). It is this product's only package size.

NDC 65145-0161-01
🏷️ FDA NDC (as labeled) 65145-161-01 billing pads the product 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 →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65145-161-01
Product NDC 65145-161
11-digit billing NDC 65145016101
NCPDP billing unit ML — per mL (volume)
RxCUI 804544
UNII S8A06QG2QE
UPC 0365145161017
Application # ANDA219441
SPL Set ID 0f9a1987-6a04-4764-94e5-7053997c058b
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-12-26
Route OPHTHALMIC
Dosage form EMULSION
Substance DIFLUPREDNATE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 86300012001620
GCN Seq No 064354
GCN 13635
HICL code 011782
Ingredient (HICL) Difluprednate
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 Q6P
Therapeutic class — specific (HIC3) Eye Anti-Inflammatory Agents
AHFS code 52:08.08.00
AHFS class Corticosteroids (Eent)
FDB label name DIFLUPREDNATE 0.05% EYE DROP
FDB brand name Difluprednate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 064354
  • GCN: 13635
  • GPI-14 (Medi-Span): 86300012001620
  • HICL (First Databank): 011782
  • AHFS class code: 52:08.08.00
  • RxCUI (RxNorm): 804544
Why two NDCs? The FDA registers this code as 65145-161-01 — 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 → 65145-0161-01. 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 Corticosteroids, potent (group III) class.

Drug family (ATC) Corticosteroids, potent (group III), Corticosteroids, plain
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 DIFLUPREDNATE 0.05% EYE DROP Ingredient Difluprednate
📗 Our plain-language guide HelloPharmacist
  • It treats inflammation and pain after eye surgery. It is also used for endogenous anterior uveitis, which is inflammation in the front of the eye.
  • Put one drop in the affected eye as prescribed. Usually that's several times a day at first, then tapering down. Keep the dropper tip from touching your eye or anything else so the...
  • Take them out before using the drops. The preservative can be absorbed by soft lenses. You can put them back in after 10 minutes, if your eye doctor says it's okay.
  • Eye pain, redness, light sensitivity, swelling, blurred vision and irritation are the most common. Some may be from the surgery itself. Call your doctor if things get worse or don'...
📖 Read our full Difluprednate 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 $9.687 $48.43 / 5 ml
Medicaid paysCMS SDUD · 12 mo $14.12 $70.62 / 5 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $10.460 $7.048
▼ Down 5% over the last 10 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 Marketing startMarketing endStatus
65145-0161-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE 2024-12-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Difluprednate .5 mg/mL 00378-7518-35 Mylan 1 bottle $9.687 AB Availability likely —
Difluprednate Ophthalmic .5 mg/mL 00781-6000-78 Sandoz 1 bottle $9.687 AB Availability likely —
Difluprednate .5 mg/mL 00832-6054-05 Upsher-Smith 1 bottle $9.687 AB Availability likely —
Difluprednate Ophthalmic Emulsion .5 mg/mL 43598-0588-11 Dr. 1 bottle $9.687 AB Availability likely —
Difluprednate .5 mg/mLthis 65145-0161-01 Caplin 1 bottle $9.687 AB Availability likely —
Difluprednate .5 mg/mL 69238-1380-03 Amneal 1 bottle $9.687 AB Availability likely —
Difluprednate .5 mg/mL 69315-0329-05 Leading 1 bottle $9.687 AB Availability likely —
Difluprednate .5 mg/mL 69097-0341-35 Cipla 1 bottle $9.786 AB FDA listed +1%
Durezol .5 mg/mL 66758-0086-75 Sandoz 1 bottle $42.249 AB Availability likely +336%
Difluprednate .5 mg/mL 46708-0750-05 Alembic 1 bottle — AB FDA listed —
Difluprednate .5 mg/mL 62332-0750-05 Alembic 1 bottle — 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

🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII R57ZHV85D4
    Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
  • UNII D5340Y2I9G
    Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 4550K0SC9B
    Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerCaplin Steriles Limited
Application holderCAPLIN STERILES LTD
FDA applicationANDA219441 (ANDA)
Labeler code65145
First marketedDec 2024
Product typeHuman Prescription Drug
Portfolio88 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.

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 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 77 words ▾

1 INDICATIONS AND USAGE Difluprednate ophthalmic emulsion is a topical corticosteroid that is indicated for: The treatment of inflammation and pain associated with ocular surgery. ( 1.1 ) The treatment of endogenous anterior uveitis. ( 1.2 )

1.1Ocular Surgery Difluprednate ophthalmic emulsion 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery.

1.2Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion is also indicated for the treatment of endogenous anterior uveitis.

⏱️ Dosage and Administration 173 words ▾

2 DOSAGE AND ADMINISTRATION For the treatment of inflammation and pain associated with ocular surgery instill one drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response. ( 2.1 ) For the treatment of endogenous anterior uveitis instill one drop into the conjunctival sac of the affected eye 4 times daily for 14 days followed by tapering as clinically indicated.

( 2.2 )

2.1Ocular Surgery Instill one drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response.

2.2Endogenous Anterior Uveitis Instill one drop into the conjunctival sac of the affected eye 4 times daily for 14 days followed by tapering as clinically indicated.

💊 Dosage Forms and Strengths 39 words ▾

3 DOSAGE FORMS AND STRENGTHS Difluprednate ophthalmic emulsion contains 0.05% difluprednate as a sterile preserved emulsion for topical ophthalmic administration. Difluprednate ophthalmic emulsion contains 0.05% difluprednate, as a sterile preserved ophthalmic emulsion for topical ophthalmic use only.( 3 )

⛔ Contraindications 95 words ▾

4 CONTRAINDICATIONS The use of difluprednate ophthalmic emulsion, as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. Difluprednate ophthalmic emulsion, as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Intraocular pressure (IOP) increase- Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored. ( 5.1 ) Cataracts- Use of corticosteroids may result in posterior subcapsular cataract formation.

( 5.2 ) Delayed healing- The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order beyond 28 days should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

( 5.3 ) Bacterial infections- Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.

( 5.4 ) Viral infections- Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). ( 5.5 ) Fungal infections- Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application.

Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. ( 5.6 ) To report SUSPECTED ADVERSE REACTIONS, contact Caplin Steriles Limited at 1-866-978-6111 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

5.1IOP Increase Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, intraocular pressure should be monitored.

5.2Cataracts Use of corticosteroids may result in posterior subcapsular cataract formation.

5.3Delayed Healing The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order beyond 28 days should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

5.4Bacterial Infections Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.

5.5Viral Infections Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).

5.6Fungal Infections Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate.

5.7Topical Ophthalmic Use Only Difluprednate ophthalmic emulsion is not indicated for intraocular administration.

5.8Contact Lens Wear Difluprednate ophthalmic emulsion should not be instilled while wearing contact lenses. Remove cont… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following serious reactions are found elsewhere in the labeling: • Elevated intraocular pressure [see Warnings and Precautions ( 5.1 )] • Posterior subcapsular cataract formation [see Warnings and Precautions ( 5.2 )] • Secondary ocular infection [see Warnings and Precautions ( 5.4 )] • Perforation of the globe [see Warnings and Precautions ( 5.3 )]

6.1Ocular Surgery Ocular adverse reactions occurring in 5 - 15% of subjects in clinical studies with difluprednate ophthalmic emulsion included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis. Other ocular adverse reactions occurring in 1 - 5% of subjects included reduced visual acuity, punctate keratitis, eye inflammation, and iritis. Ocular adverse reactions occurring in < 1% of subjects included application site discomfort or irritation, corneal pigmentation and striae, episcleritis, eye pruritis, eyelid irritation and crusting, foreign body sensation, increased lacrimation, macular edema, sclera hyperemia, and uveitis.

Most of these reactions may have been the consequence of the surgical procedure.

6.2Endogenous Anterior Uveitis A total of 200 subjects participated in the clinical trials for endogenous anterior uveitis, of which 106 were exposed to difluprednate ophthalmic emulsion. The most common adverse reactions of those exposed to difluprednate ophthalmic emulsion occurring in 5 - 10% of subjects included blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis, and uveitis. Adverse reactions occurring in 2 - 5% of subjects included anterior chamber flare, corneal edema, dry eye, iridocyclitis, photophobia, and reduced visual acuity.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category C. Difluprednate has been shown to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal anomalies) when administered subcutaneously to rabbits during organogenesis at a dose of 1 - 10 mcg/kg/day. The no-observed-effect-level (NOEL) for these effects was 1 mcg/kg/day and 10 mcg/kg/day was considered to be a teratogenic dose that was concurrently found in the toxic dose range for fetuses and pregnant females.

Treatment of rats with 10 mcg/kg/day subcutaneously during organogenesis did not result in any reproductive toxicity, nor was it maternally toxic. At 100 mcg/kg/day after subcutaneous administration in rats, there was a decrease in fetal weights and delay in ossification, and effects on weight gain in the pregnant females. It is difficult to extrapolate these doses of difluprednate to maximum daily human doses of difluprednate ophthalmic emulsion, since difluprednate ophthalmic emulsion is administered topically with minimal systemic absorption, and difluprednate blood levels were not measured in the reproductive animal studies.

However, since use of difluprednate during human pregnancy has not been evaluated and cannot rule out the possibility of harm, difluprednate ophthalmic emulsion should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus.

8.3Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when difluprednate ophthalmic emulsion is administered to a nursing woman.

8.4Pediatric Use Difluprednate ophthalmic emulsion was evaluated in a 3-month multicenter, double-masked trial in 79 pediatric patients (39 difluprednate; 40 prednisolone acetate) 0 to 3 years of age for the treatment of inflammation following cataract surgery. A similar safety profile was observed in pediatric patients comparing difluprednate ophthalmic emulsion to prednisolone acetate ophthalmic suspension, 1%.

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

🤰 Pregnancy 210 words ▾

8.1Pregnancy Pregnancy Category C. Difluprednate has been shown to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal anomalies) when administered subcutaneously to rabbits during organogenesis at a dose of 1 - 10 mcg/kg/day. The no-observed-effect-level (NOEL) for these effects was 1 mcg/kg/day and 10 mcg/kg/day was considered to be a teratogenic dose that was concurrently found in the toxic dose range for fetuses and pregnant females.

Treatment of rats with 10 mcg/kg/day subcutaneously during organogenesis did not result in any reproductive toxicity, nor was it maternally toxic. At 100 mcg/kg/day after subcutaneous administration in rats, there was a decrease in fetal weights and delay in ossification, and effects on weight gain in the pregnant females. It is difficult to extrapolate these doses of difluprednate to maximum daily human doses of difluprednate ophthalmic emulsion, since difluprednate ophthalmic emulsion is administered topically with minimal systemic absorption, and difluprednate blood levels were not measured in the reproductive animal studies.

However, since use of difluprednate during human pregnancy has not been evaluated and cannot rule out the possibility of harm, difluprednate ophthalmic emulsion should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus.

🧒 Pediatric Use 56 words ▾

8.4Pediatric Use Difluprednate ophthalmic emulsion was evaluated in a 3-month multicenter, double-masked trial in 79 pediatric patients (39 difluprednate; 40 prednisolone acetate) 0 to 3 years of age for the treatment of inflammation following cataract surgery. A similar safety profile was observed in pediatric patients comparing difluprednate ophthalmic emulsion to prednisolone acetate ophthalmic suspension, 1%.

🧓 Geriatric Use 18 words ▾

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

🧬 Clinical Pharmacology 199 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Corticosteroids inhibit the inflammatory response to a variety of inciting agents and may delay or slow healing. They inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids.

However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotreines by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Difluprednate is structurally similar to other corticosteroids.

12.3Pharmacokinetics Difluprednate undergoes deacetylation in vivo to 6α, 9-difluoroprednisolone 17-butyrate (DFB), an active metabolite of difluprednate. Clinical pharmacokinetic studies of difluprednate after repeat ocular instillation of 2 drops of difluprednate (0.01% or 0.05%) 4 times per day for 7 days showed that DFB levels in blood were below the quantification limit (50 ng/mL) at all time points for all subjects, indicating the systemic absorption of difluprednate after ocular instillation of difluprednate ophthalmic emulsion is limited.

🧬 Mechanism of Action 120 words ▾

12.1Mechanism of Action Corticosteroids inhibit the inflammatory response to a variety of inciting agents and may delay or slow healing. They inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids.

However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotreines by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Difluprednate is structurally similar to other corticosteroids.

📦 How Supplied / Storage and Handling 76 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Difluprednate ophthalmic emulsion 0.05% is a sterile, aqueous topical ophthalmic emulsion supplied in an opaque plastic bottle with a controlled drop tip and a pink cap in the following sizes:5 mL in a 5 mL bottle NDC 65145-161-01 Storage and Handling Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light. When not in use, keep the bottles in the protective carton.

📋 Description 107 words ▾

11 DESCRIPTION Difluprednate ophthalmic emulsion 0.05% is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. The chemical name is 6α, 9difluoro-11β,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate 17-butyrate (CAS number 23674-86-4). Difluprednate is represented by the following structural formula: Difluprednate has a molecular weight of 508.56 g/mol, and the molecular formula is C 27 H 34 F 2 O 7 .

Each mL contains: ACTIVE: difluprednate 0.5 mg (0.05%); INACTIVE: boric acid, castor oil, glycerin, polysorbate 80, water for injection, sodium acetate, edetate disodium, sodium hydroxide (to adjust the pH to 5.2 to 5.8). The emulsion is essentially isotonic with a tonicity of 304 to 411 mOsm/kg. PRESERVATIVE: sorbic acid 0.1%. difluprednate-structure

💬 Information for Patients 149 words ▾

17 PATIENT COUNSELING INFORMATION

17.1Risk of Contamination This product is sterile when packaged. Advise patients not to allow the dropper tip to touch any surface, as this may contaminate the emulsion. Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery.

17.2Risk of Secondary Infection If pain develops, or if redness, itching, or inflammation becomes aggravated, advise patients to consult a physician.

17.3Contact Lens Wear Difluprednate ophthalmic emulsion should not be instilled while wearing contact lenses. Advise patients to remove contact lenses prior to instillation of difluprednate ophthalmic emulsion. The preservative in difluprednate ophthalmic emulsion may be absorbed by soft contact lenses.

Lenses may be reinserted after 10 minutes following administration of difluprednate ophthalmic emulsion. Made in India Distributed by : Caplin Steriles USA Inc, Hamilton, NJ 08619. Code: TN/Drugs/TN00003457 Revised: 12/2024 22201094 difluprednate-caplin-logo

🍼 Nursing Mothers 61 words ▾

8.3Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when difluprednate ophthalmic emulsion is administered to a nursing woman.

🧬 Pharmacokinetics 76 words ▾

12.3Pharmacokinetics Difluprednate undergoes deacetylation in vivo to 6α, 9-difluoroprednisolone 17-butyrate (DFB), an active metabolite of difluprednate. Clinical pharmacokinetic studies of difluprednate after repeat ocular instillation of 2 drops of difluprednate (0.01% or 0.05%) 4 times per day for 7 days showed that DFB levels in blood were below the quantification limit (50 ng/mL) at all time points for all subjects, indicating the systemic absorption of difluprednate after ocular instillation of difluprednate ophthalmic emulsion is limited.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES

14.1Ocular Surgery Clinical efficacy was evaluated in 2 randomized, double-masked, placebo-controlled trials in which subjects with an anterior chamber cell grade ≥ "2" (a cell count of 11 or higher) after cataract surgery were assigned to difluprednate ophthalmic emulsion or placebo (vehicle) following surgery. One drop of difluprednate ophthalmic emulsion or vehicle was self-instilled either 2 times per day or 4 times per day for 14 days, beginning the day after surgery. The presence of complete clearing (a cell count of 0) was assessed 3, 8, and 15 days post-surgery using a slit lamp binocular microscope.

In the intent-to-treat analyses of both studies, a significant benefit was seen in the 4 times per day (QID) difluprednate ophthalmic emulsion-treated group in ocular inflammation, at Days 8 and 15, and reduction of pain at Days 3, 8, and 15 when compared with placebo. The consolidated clinical trial results are provided below. fig-1 fig-2

14.2Endogenous Anterior Uveitis Clinical efficacy was evaluated in two randomized, double masked active controlled trials in which patients who presented with endogenous anterior uveitis were treated with either difluprednate ophthalmic emulsion 4 times daily or prednisolone acetate ophthalmic suspension 1%, 8 times daily for 14 days. Both studies demonstrated that difluprednate ophthalmic emulsion was equally effective as prednisolone acetate ophthalmic suspension 1% in treating subjects with endogenous anterior uveitis.

Mean Change from Baseline in Anterior Chamber Cell Grade* Study 1 Time Point Difluprednate Ophthalmic Emulsion N = 57 Prednisolone Acetate N = 53 Difference † (95% CI) Baseline 2.6 2.5 0.0 (-0.22, 0.28) Day 3 -1.0 -1.0 -0.1 (-0.35, 0.25) Day 7 -1.6 -1.5 -0.0 (-0.31, 0.25) Day 14 -2.0 -1.8 -0.2 (-0.46, 0.10) Day 21 -2.2 -1.9 -0.3 (-0.53, 0.01) Day 28 -2.2 -2.1 -0.1 (-0.37, 0.18) Day 35 -2.1 -2.0 -0.1 (-0.39, 0.20) Day 42 -2.1 -2.1 0.0 (-0.27, 0.34) Study 2 Time Point Difluprednate Ophthalmic Emulsion N = 50 Prednisolone Acetate N = 40 Difference † (95% CI) Baseline 2.4 2.4 0.0 (-0.21, 0.29) Day 3 -0.9 -0.9 -0.0 (-0.34, 0.25) Day 7 -1.7 -1.6 -0.1 (-0.35, 0.21) Day 14 -1.9 -1.8 -0.1 (-0.34, 0.20) Day 21 -2.0 -2.0 0.0 (-0.25, 0.28) Day 28 -2.0 -2.0 0.0 (-0.21, 0.26) Day 35 -2.1 -2.0 -0.1 (-0.32, 0.16) Day 42 -2.0 -1.9 -0.1 (-0.36, 0.24) *With 5 grades: 0 = 0 cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = > 50 cells. † Adjusted for baseline AC cell grade and study center and based on ITT dataset with LOCF for missing data.

🧪 Nonclinical Toxicology 189 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, and Impairment of Fertility Difluprednate was not genotoxic in vitro in the Ames test, and in cultured mammalian cells CHL/IU (a fibroblastic cell line derived from the lungs of newborn female Chinese hamsters). An in vivo micronucleus test of difluprednate in mice was also negative. Treatment of male and female rats with subcutaneous difluprednate up to 10 mcg/kg/day prior to and during mating did not impair fertility in either gender.

Long term studies have not been conducted to evaluate the carcinogenic potential of difluprednate.

13.2Animal Toxicology and/or Pharmacology In multiple studies performed in rodents and non-rodents, subchronic and chronic toxicity tests of difluprednate showed systemic effects such as suppression of body weight gain; a decrease in lymphocyte count; atrophy of the lymphatic glands and adrenal gland; and for local effects, thinning of the skin; all of which were due to the pharmacologic action of the molecule and are well known glucocorticosteroid effects. Most, if not all of these effects were reversible after drug withdrawal.

The NOEL for the subchronic and chronic toxicity tests were consistent between species and ranged from 1-1.25 mcg/kg/day.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 87 words ▾

13.1Carcinogenesis, Mutagenesis, and Impairment of Fertility Difluprednate was not genotoxic in vitro in the Ames test, and in cultured mammalian cells CHL/IU (a fibroblastic cell line derived from the lungs of newborn female Chinese hamsters). An in vivo micronucleus test of difluprednate in mice was also negative. Treatment of male and female rats with subcutaneous difluprednate up to 10 mcg/kg/day prior to and during mating did not impair fertility in either gender.

Long term studies have not been conducted to evaluate the carcinogenic potential of difluprednate.

📄 Package Label / Principal Display Panel 40 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65145- 161 -01 Rx only Difluprednate Ophthalmic Emulsion 0.05% For eye use only Sterile 5 mL NDC 65145- 161 -01 Rx only Difluprednate Ophthalmic Emulsion 0.05% For eye use only Sterile 5 mL difluprednate-container-5ml difluprednate-carton-5ml

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.
📅 Q2 2025 – Q4 2025 · 3 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
41
Units reimbursed last 4 qtrs
210
Gross reimbursed last 4 qtrs
$3K
Avg / prescription
$72.34
Avg / unit
$14.1232
Latest quarter Q4 2025
13Rx
Medicaid pays / mL
$14.1232
gross reimbursed
vs
NADAC / mL
$9.6866
acquisition cost
=
Spread
+$4.4366
+46% vs cost
What Medicaid paid per mL (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 ⓘ
100% FFS
Fee-for-service · 41 Rx Managed care · 0 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: 210 units · 1.1 per 100k residents 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: no data reported 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
1.11.1
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 1.1 /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.

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

Medicare Part D (outpatient prescription) spending for Difluprednate — the program that covers self-administered drugs. 9 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 Difluprednate. 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
$3.37M
Claims incl. refills
34.2K
Beneficiaries
23.8K
Spend / beneficiary
$142.07
Spend / claim
$98.73
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.
← 65145-0158-25 · Caplin 65145-0162-01 · Caplin →
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.