Prednisolone Acetate 10 mg/mL Suspension/ Drops
Other active recalls for Prednisolone Acetate (different manufacturers) — 2 · tap to view
Past resolved recalls for this product (1)
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Ophthalmic prednisolone reduces the irritation, redness, burning, and swelling of eye inflammation caused by chemicals, heat, radiation, infection, allergy, or foreign bodies in the eye. It sometimes is used after eye surgery. Prednisolone is in a class of medications called steroids. It prevents swelling and redness by changing the way the immune system works.
Read the full MedlinePlus article ↗- Prednisolone is a steroid that calms inflammation and dials down an overactive immune system. Depending on what you're being treated for — whether that's an asthma flare, a skin co...
- Why has my doctor prescribed prednisolone — what is it actually doing?
- Please don't stop on your own — this is one of the most important things to know about prednisolone. When you take it for more than a short time, your adrenal glands slow down thei...
- Can I stop taking prednisolone when I start feeling better?
Patient education
Supplement & herbal interactions
Prednisolone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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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.
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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.
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Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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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.
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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.
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UNII GR686LBA74
Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
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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?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $4.394 | $65.91 / 15 ml |
| Medicaid paysCMS SDUD · 12 mo | $5.13 | $76.89 / 15 ml |
| Medicare drug plans payPart D · Q2 2026 | $5.35 | $80.18 / 15 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| prednisolone acetate 10 mg/mL 60219-2552-01 | Amneal | 1 bottle | $4.394 | AB | Availability likely | — |
| Prednisolone Acetate 10 mg/mLthis 61314-0637-15 | Sandoz | 1 bottle | $4.394 | AB | Availability likely | — |
| prednisolone acetate 10 mg/mL 60219-2551-01 | Amneal | 1 bottle | $4.450 | AB | Availability likely | +1% |
| prednisolone acetate 10 mg/mL 60219-2550-01 | Amneal | 1 bottle | $4.589 | AB | Availability likely | +4% |
| Prednisolone Acetate 10 mg/mL 60758-0119-05 | Pacific | 1 bottle | $4.589 | AB | Availability likely | +4% |
| Prednisolone Acetate 10 mg/mL 70748-0332-02 | Lupin | 1 bottle | $4.589 | AB | Availability likely | +4% |
| Pred Forte 10 mg/mL 11980-0180-01 | Allergan, | 1 bottle | — | AB | Discontinued | — |
| Prednisolone Acetate 10 mg/mL 50090-0559-00 | A-S | 1 bottle | — | AB | FDA listed | — |
| Prednisolone Acetate 10 mg/mL 50090-1912-00 | A-S | 1 bottle | — | AB | FDA listed | — |
| Prednisolone Acetate 10 mg/mL 50090-5275-00 | A-S | 1 bottle | — | AB | FDA listed | — |
| Prednisolone Acetate 10 mg/mL 50090-7539-00 | A-S | 1 bottle | — | AB | FDA listed | — |
| Prednisolone Acetate 10 mg/mL 67296-2176-05 | Redpharm | 1 bottle | — | AB | FDA listed | — |
| Prednisolone Acetate 10 mg/mL 68071-2222-05 | NuCare | 1 bottle | — | AB | FDA listed | — |
| Prednisolone Acetate 10 mg/mL 76420-0204-05 | Asclemed | 1 bottle | — | AB | FDA listed | — |
| Prednisolone Acetate 10 mg/mL 85766-0124-05 | Sportpharm | 1 bottle | — | AB | FDA listed | — |
| Prednisolone Acetate 10 mg/mL 85766-0258-05 | Sportpharm | 1 bottle | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 61314-0637-05 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-637-05) / 5 mL in 1 BOTTLE, PLASTIC | $4.59 / mL | $22.94 | 1994-12-15 | Active |
| 61314-0637-10 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-637-10) / 10 mL in 1 BOTTLE, PLASTIC | $4.45 / mL | $44.50 | 1994-12-15 | Active |
| 61314-0637-15 You're viewing this | 1 BOTTLE, PLASTIC in 1 CARTON (61314-637-15) / 15 mL in 1 BOTTLE, PLASTIC | $4.39 / mL | $65.91 | 1994-12-15 | Active |
This pack has the lowest per-mL cost of the 3 priced pack sizes ($4.39 NADAC).
This pack accounts for about 3.9% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 61314-0637-15?
What NDC number is used to bill for this package of Prednisolone Acetate 10 mg/mL Suspension/ Drops?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE: Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: SHAKE WELL BEFORE USING . Two drops topically in the affected eye(s) four times daily. In cases of bacterial infections, concomitant use of anti-infective agents is mandatory.
Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be reevaluated (see PRECAUTIONS ). The dosing of prednisolone acetate ophthalmic suspension may be reduced, but care should be taken not to discontinue therapy prematurely.
In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.
⛔ Contraindications ▾
CONTRAINDICATIONS: Prednisolone acetate ophthalmic suspension is contraindicated in most 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. Prednisolone acetate ophthalmic suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
⚠️ Warnings ▾
WARNINGS: FOR TOPICAL OPHTHALMIC USE. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.
Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.
If this product is used for 10 days or longer, intraocular pressure (IOP) should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. IOP should be checked frequently.
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.
Corticosteroids are not effective in mustard gas keratitis and Sjogren's keratoconjunctivitis.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: Adverse reactions include, in decreasing order of frequency, elevation of IOP with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing. Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical steroids. Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe.
Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids. The development of secondary ocular infection (bacterial, fungal and viral) has occurred. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid.
The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (see WARNINGS ). The following additional adverse reactions have been reported with prednisolone use: Cushing’s syndrome and adrenal suppression may occur after very frequent use of ophthalmic prednisolone, particularly in very young children.
🤰 Pregnancy ▾
Pregnancy:
🧒 Pediatric Use ▾
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY: Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the 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 leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Corticosteroids are capable of producing a rise in intraocular pressure.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Prednisolone acetate ophthalmic suspension is supplied in a white, round low density polyethylene dispenser with a natural low density polyethylene dispensing plug and pink polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package. Prednisolone Acetate Suspension, USP, 1%: 5 mL NDC 61314-637-05 10 mL NDC 61314-637-10 15 mL NDC 61314-637-15 STORAGE: Store at 8°C to 24°C (46°F to 75°F) in an UPRIGHT position.
After opening, prednisolone acetate ophthalmic suspension can be used until the expiration date on the bottle. Rx Only Distributed by Sandoz Inc. Princeton, NJ 08540 Rev.
Dec 2024
📋 Description ▾
DESCRIPTION: Prednisolone acetate ophthalmic suspension is an adrenocortical steroid product prepared as sterile ophthalmic suspension for topical ophthalmic use. The active ingredient is represented by the chemical structure: Established name: Prednisolone Acetate Chemical name: Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-,(11β)-. Each mL contains: Active : prednisolone acetate 1.0%.
Preservative : benzalkonium chloride 0.01%. Inactives: citric acid monohydrate (to adjust pH), dibasic sodium phosphate, edetate disodium, glycerin, hypromellose, polysorbate 80, purified water, sodium hydroxide (to adjust pH). chemical
💬 Information for Patients ▾
Information for Patients: If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician. This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface.
The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of the reach of children.