PREDNISOLONE ACETATE 10 mg/mL Suspension/ Drops
Other active recalls for Prednisolone Acetate (different manufacturers) — 2 · tap to view
🆔 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
- 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 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.
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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 5EYA69XGAT
Hypromellose is a plant-derived thickener and film-former used in medicine coatings and tablets. It helps control how fast the drug dissolves and protects the medicine's contents.
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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 TZX5469Z6I
Sodium bisulfite is a chemical salt used as a preservative and antioxidant in medicines. It prevents discoloration and degradation of active ingredients, especially in liquid formulations and injectables.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII B22547B95K
A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
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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 | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $5.35 | $26.73 / 5 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/mL 60219-2551-01 | Amneal | 1 bottle | $4.450 | AB | Availability likely | — |
| prednisolone acetate 10 mg/mL 60219-2550-01 | Amneal | 1 bottle | $4.589 | AB | Availability likely | — |
| Prednisolone Acetate 10 mg/mL 60758-0119-05 | Pacific | 1 bottle | $4.589 | AB | Availability likely | — |
| Prednisolone Acetate 10 mg/mL 61314-0637-05 | Sandoz | 1 bottle | $4.589 | AB | Availability likely | — |
| Prednisolone Acetate 10 mg/mL 70748-0332-02 | Lupin | 1 bottle | $4.589 | AB | Availability likely | — |
| 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/mLthis 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
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?
📊 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 | Marketing start | Status |
|---|---|---|---|
| 67296-2176-05 You're viewing this | 1 BOTTLE in 1 CARTON (67296-2176-5) / 5 mL in 1 BOTTLE | 2024-10-11 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Prednisolone acetate ophthalmic suspension is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Shake well before using. Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated ( see PRECAUTIONS ).
⛔ Contraindications ▾
CONTRAINDICATIONS Prednisolone acetate ophthalmic suspension is contraindicated in acute untreated purulent ocular infections, 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 Prolonged use of corticosteroids may result in posterior subcapsular cataract formation and may increase intraocular pressure in susceptible individuals, resulting in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. If this product is used for 10 days or longer, intraocular pressure 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. Intraocular pressure should be checked frequently. 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. 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. Prednisolone acetate ophthalmic suspension contains sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions have been identified during use of Prednisolone acetate ophthalmic suspension. Because reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions include elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.
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 steroids. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used ( see PRECAUTIONS ).
Other adverse reactions reported with the use of prednisolone acetate ophthalmic suspension include: allergic reactions; dysgeusia; eye pain; foreign body sensation; headache; pruritus; rash; transient burning and stinging upon instillation and other minor symptoms of ocular irritation; urticaria; and visual disturbance (blurry vision). Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.
Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe. To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🤰 Pregnancy ▾
Pregnancy Prednisolone has been shown to be teratogenic in mice when given in doses 1 to 10 times the human dose. Dexamethasone, hydrocortisone, and prednisolone were ocularly applied to both eyes of pregnant mice five times per day on days 10 through 13 of gestation. A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice.
There are no adequate well-controlled studies in pregnant women. Prednisolone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use The safety and effectiveness in pediatric patients have been established. Use in pediatric patients is supported by evidence from adequate and well-controlled studies of prednisolone acetate ophthalmic suspension in adults with additional data in pediatric patients.
🧓 Geriatric Use ▾
Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🆘 Overdosage ▾
OVERDOSAGE Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Prednisolone acetate is a glucocorticoid that, on the basis of weight, has 3 to 5 times the anti-inflammatory potency of hydrocortisone. Glucocorticoids inhibit the edema, fibrin deposition, capillary dilation, and phagocytic migration of the acute inflammatory response, as well as capillary proliferation, deposition of collagen, and scar formation.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Prednisolone acetate ophthalmic suspension USP, 1% is supplied sterile in opaque white bottle with opaque white nozzle with pink cap as follows: NDC 70748-332-02: 5 mL in 10 mL bottle NDC 70748-332-03: 10 mL in 15 mL bottle NDC 70748-332-04: 15 mL in 15 mL bottle Storage: Store at up to 25°C (77°F). Protect from freezing. Store in an upright position.
LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc. Manufactured for: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States.
Manufactured by: Lupin Limited Pithampur (M. P.) - 454 775 India. Revised: December 2024 ID#: 275716 Image
📋 Description ▾
DESCRIPTION Prednisolone acetate ophthalmic suspension USP, 1% is a sterile, topical anti-inflammatory agent for ophthalmic use. Its chemical name is 11ß,17, 21-Trihydroxypregna-1,4-diene-3, 20-dione 21-acetate and it has the following structure: Each mL of prednisolone acetate ophthalmic suspension USP contains: Active: prednisolone acetate (micronized) 1% Inactive: benzalkonium chloride as preservative, boric acid, edetate disodium, hypromellose, polysorbate 80, sodium bisulfite, sodium chloride, sodium citrate and water for injection.
The pH during its shelf life ranges from 5.0 to 6.0. Structure
💬 Information for Patients ▾
Information for Patients Advise patients that if eye inflammation or pain persists longer than 48 hours or becomes aggravated, they should consult a physician. Advise patients that to prevent eye injury or 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. Advise patients that prednisolone acetate ophthalmic suspension contains benzalkonium chloride, which may be absorbed by soft contact lenses.
Contact lenses should be removed prior to application of prednisolone acetate ophthalmic suspension and may be reinserted 15 minutes following its administration.