Prednisolone Acetate 10 mg/mL Suspension/ Drops — NDC 61314-637-10 (Billing 61314-0637-10)
This is a package of Prednisolone Acetate 10 mg/mL Suspension/ Drops from Sandoz Inc, marketed since Dec 1994 and currently FDA-listed; retail pharmacies pay about $4.72 per mL (NADAC).
NDC database record
One package, one record: these facts belong to NDC 61314-637-10 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 61314 labeler · 637 product · 10 package
- Package marketed since
- Dec 15, 1994
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 6131463710 9
- Medicaid fills, this package
- 28,142 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
Past resolved recalls for this product (1)
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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 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 | $4.722 | $47.22 / 10 ml |
| Medicaid paysCMS SDUD · 12 mo | $5.47 | $54.67 / 10 ml |
| Medicare drug plans payPart D · Q2 2026 | $5.35 | $53.45 / 10 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- 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 | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 61314-0637-05 61314-637-05 Main listing | 1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC | $4.83 / mL | $24.14 | 1994-12-15 | — | Active |
| 61314-0637-10 You're viewing this | 1 BOTTLE, PLASTIC in 1 CARTON / 10 mL in 1 BOTTLE, PLASTIC | $4.72 / mL | $47.22 | 1994-12-15 | — | Active |
| 61314-0637-15 61314-637-15 | 1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC | $4.46 / mL | $66.83 | 1994-12-15 | — | Active |
Per mL, this pack runs about 6% above the cheapest pack (NDC 61314-0637-15, $4.46 vs $4.72 NADAC).
This pack accounts for about 14% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in this package?
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.
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 6% |
| prednisolone acetate 10 mg/mL 60219-2551-01 | Amneal | 1 bottle | $4.722 | AB | Availability likely | — |
| Prednisolone Acetate 10 mg/mLthis 61314-0637-10 | Sandoz | 1 bottle | $4.722 | AB | Availability likely | — |
| prednisolone acetate 10 mg/mL 60219-2550-01 | Amneal | 1 bottle | $4.827 | AB | Availability likely | +2% |
| Prednisolone Acetate 10 mg/mL 60758-0119-05 | Pacific | 1 bottle | $4.827 | AB | Availability likely | +2% |
| Prednisolone Acetate 10 mg/mL 70748-0332-02 | Lupin | 1 bottle | $4.827 | AB | Availability likely | +2% |
| 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 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
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?
- 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.
🧪 Avoiding an ingredient? See Prednisolone inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 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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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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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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 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 Sandoz Inc labeler code 61314
- CIMERLI ranibizumab-eqrn .3 mg/.05mL Injection, Solution NDC 61314-624-94
- CIMERLI ranibizumab-eqrn .5 mg/.05mL Injection, Solution NDC 61314-625-94
- Polymyxin B Sulfate and Trimethoprim 10000 [USP'U]/mL; 1 mg/mL Solution NDC 61314-628-10
- Neomycin and Polymyxin B Sulfates and Dexamethasone neomycin sulfate, polymyxin b sulfate 3.5 mg/mL; 10000 [USP'U]/mL; 1 mg/mL Suspension NDC 61314-630-06
- Neomycin and Polymyxin B Sulfates and Dexamethasone 3.5 mg/g; 10000 [iU]/g; 1 mg/g Ointment NDC 61314-631-36
- Gentamicin Sulfate 3 mg/mL Solution NDC 61314-633-05
- Neomycin and Polymyxin B Sulfates and Hydrocortisone neomycin sulfate, polymyxin b sulfate 3.5 mg/mL; 10000 [USP'U]/mL; 10 mg/mL Suspension NDC 61314-641-75
- Tobramycin 3 mg/mL Solution NDC 61314-643-05
- Neomycin and Polymyxin B Sulfates and Hydrocortisone neomycin sulfate, polymyxin b sulfate 3.5 mg/mL; 10000 [USP'U]/mL; 10 mg/mL Suspension NDC 61314-645-11
- Neomycin and Polymyxin B Sulfates and Hydrocortisone neomycin sulfate, polymyxin b sulfate 3.5 mg/mL; 10000 [iU]/mL; 10 mg/mL Solution NDC 61314-646-10
- Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL Suspension/ Drops NDC 61314-647-05
- PYZCHIVA ustekinumab-ttwe 45 mg/.5mL Injection, Solution NDC 61314-651-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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.
⚠️ Precautions ▾
PRECAUTIONS: General: The initial prescription and renewal of the medication order 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 two days, the patient should be reevaluated. 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. If this product is used for 10 days or longer, IOP should be monitored (see WARNINGS ). 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. Carcinogenesis, Mutagenesis, Impairment of Fertility: No studies have been conducted in animals or in humans to evaluate the potential of these effects.
Pregnancy: Teratogenic effects. Prednisolone has been shown to be teratogenic in mice when given in doses 1-10 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 and well controlled studies in pregnant women. Prednisolone acetate ophthalmic suspension 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 administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human 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 acetate, 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.
🍼 Nursing Mothers ▾
Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human 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 acetate, 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 61314-637-05 Rx only prednisoLONE Acetate Ophthalmic Suspension, USP 1% STERILE 5 mL SANDOZ 5mlcarton