prednisolone acetate 10 mg/mL Suspension/ Drops — NDC 60219-2550-1 (Billing 60219-2550-01)
This is a package of prednisolone acetate 10 mg/mL Suspension/ Drops from Amneal Pharmaceuticals NY LLC, marketed since Jun 2025 and currently FDA-listed; retail pharmacies pay about $4.83 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 60219-2550-1 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 60219 labeler · 2550 product · 1 package
- Package marketed since
- Jun 13, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0360219255111, 0360219255210
- Medicaid fills, this package
- 2,129 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Prednisolone Acetate (different manufacturers) — 2 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 007894
- GCN: 33153
- GPI-14 (Medi-Span): 86300050101815
- HICL (First Databank): 002870
- AHFS class code: 52:08.08.00
- RxCUI (RxNorm): 1376336
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It calms inflammation and an overactive immune system. Depending on the product, that can mean allergic conditions, skin diseases, hormone problems, ulcerative colitis or Crohn's d...
- Follow your prescriber's directions. The dissolving tablets should be taken with food, and you should not split them. For eye suspensions, shake the bottle well first. Don't stop e...
- Some people notice fluid retention, higher blood sugar or blood pressure, mood changes, trouble sleeping, nausea, and more appetite with weight gain. Call your doctor for signs of...
- Often yes, but check with me first. Warfarin, diabetes medicines, aspirin or NSAIDs, water pills, digoxin, cyclosporine, and certain seizure and antibiotic medicines can interact....
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?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $4.827 | $24.14 / 5 ml |
| Medicaid paysCMS SDUD · 12 mo | $6.24 | $31.19 / 5 ml |
| Medicare drug plans payPart D · Q2 2026 | $5.35 | $26.73 / 5 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 60219-2550-01 You're viewing this Main listing | 1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC | 2025-06-13 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| prednisolone acetate 10 mg/mL 60219-2552-01 | Amneal | 1 bottle | $4.456 | AB | Availability likely | save 8% |
| prednisolone acetate 10 mg/mL 60219-2551-01 | Amneal | 1 bottle | $4.722 | AB | Availability likely | save 2% |
| prednisolone acetate 10 mg/mLthis 60219-2550-01 | Amneal | 1 bottle | $4.827 | AB | Availability likely | — |
| Prednisolone Acetate 10 mg/mL 60758-0119-05 | Pacific | 1 bottle | $4.827 | AB | Availability likely | — |
| Prednisolone Acetate 10 mg/mL 61314-0637-05 | Sandoz | 1 bottle | $4.827 | AB | Availability likely | — |
| Prednisolone Acetate 10 mg/mL 70748-0332-02 | Lupin | 1 bottle | $4.827 | 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/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?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
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?
- FDA Orange Book · refreshed Oct 3, 2026
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 3NXW29V3WO
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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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 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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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.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Amneal Pharmaceuticals NY LLC labeler code 60219
- Deflazacort 6 mg Tablet NDC 60219-2282-1
- Deflazacort 18 mg Tablet NDC 60219-2283-1
- Deflazacort 30 mg Tablet NDC 60219-2284-1
- Deflazacort 36 mg Tablet NDC 60219-2285-1
- Tramadol Hydrochloride 50 mg Tablet, Coated NDC 60219-2348-1
- Pilocarpine Hydrochloride Ophthalmic 12.5 mg/mL Solution/ Drops NDC 60219-2366-2
- prednisolone acetate 10 mg/mL Suspension/ Drops NDC 60219-2551-1
- prednisolone acetate 10 mg/mL Suspension/ Drops NDC 60219-2552-1
- Pilocarpine Hydrochloride Ophthalmic 12.5 mg/mL Solution/ Drops NDC 60219-2649-1
- Sildenafil 10 mg/mL Powder, For Suspension NDC 60219-2651-1
- Fosfomycin Tromethamine 3 g Granule, For Solution NDC 60219-3955-1
- Fenofibrate 54 mg Tablet NDC 60219-5511-9
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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 hours 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 Amneal Pharmaceuticals LLC at 1-877-835-5472 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 a sterile white homogenous suspension supplied in 10 mL or 15 mL LDPE white opaque bottles with LDPE white opaque nozzles and HDPE pink caps. It is available as follows: 5 mL in 10 mL Container (Filled to 1/2 Capacity): NDC 60219-2550-1 10 mL in 15 mL Container (Filled to 2/3 Capacity): NDC 60219-2551-1 15 mL in 15 mL Container: NDC 60219-2552-1 Storage: Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature].
Protect from freezing. Store in an upright position. Rx only Manufactured by: Amneal Pharmaceuticals Pvt.
Ltd. Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 03-2025-00
📋 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: Structural formula: Prednisolone Acetate Molecular formula: C 23 H 30 O 6 Molecular weight: 402.48 g/mol Each mL of prednisolone acetate ophthalmic suspension USP, 1 % contains: Active: Prednisolone acetate, USP (micronized), 10 mg (1%). Preservative: Benzalkonium chloride Inactives: 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. 1
💬 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 and may be reinserted 15 minutes following its administration.
⚠️ Precautions ▾
PRECAUTIONS General The initial prescription and renewal of the medication order beyond 20 milliliters of prednisolone acetate ophthalmic suspension 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. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated. As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use.
Fungal cultures should be taken when appropriate. 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 and may be reinserted 15 minutes following its administration. Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been conducted in animals or in humans to evaluate the potential of these effects.
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. Nursing 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. Because of the potential for serious adverse reactions in nursing infants from prednisolone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 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 No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🍼 Nursing Mothers ▾
Nursing 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. Because of the potential for serious adverse reactions in nursing infants from prednisolone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been conducted in animals or in humans to evaluate the potential of these effects.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 60219-2550-1 PrednisoLONE Acetate Ophthalmic Suspension USP, 1% Rx only 5 mL Amneal Pharmaceuticals LLC NDC 60219-2551-1 PrednisoLONE Acetate Ophthalmic Suspension USP, 1% Rx only 10 mL Amneal Pharmaceuticals LLC NDC 60219-2552-1 PrednisoLONE Acetate Ophthalmic Suspension USP, 1% Rx only 15 mL Amneal Pharmaceuticals LLC 1 2 3 4 4 6