Tropicamide 10 mg/mL Solution/ Drops — NDC 61314-355-01 (Billing 61314-0355-01)
This is a package of Tropicamide 10 mg/mL Solution/ Drops from Sandoz Inc, marketed since Jun 2000 and currently FDA-listed; retail pharmacies pay about $2.64 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 61314-355-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 61314 labeler · 355 product · 01 package
- Package marketed since
- Jun 13, 2000
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 6131435501 0
- Medicaid fills, this package
- 817 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
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): 007873
- GCN: 33021
- GPI-14 (Medi-Span): 86350050002010
- HICL (First Databank): 003466
- AHFS class code: 52:24.00.00
- RxCUI (RxNorm): 314238
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 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Anticholinergic class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 8, 2026
Clinical
Tropicamide ophthalmic is used to cause pupil dilation (making the black center of the eye bigger) before an eye examination. Tropicamide is in a class of medications called mydriatics. It works by relaxing certain muscles in the eye.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
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 | $2.635 | $7.91 / 3 ml |
| Medicaid paysCMS SDUD · 12 mo | $5.46 | $16.37 / 3 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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 |
|---|---|---|---|---|---|---|
| 61314-0355-01 You're viewing this Main listing | 1 BOTTLE, PLASTIC in 1 CARTON / 3 mL in 1 BOTTLE, PLASTIC | $2.64 / mL | $7.91 | 2000-06-13 | — | Active |
| 61314-0355-02 61314-355-02 | 1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC | $0.5515 / mL | $8.27 | 2000-06-13 | — | Active |
Per mL, this pack runs about 378% above the cheapest pack (NDC 61314-0355-02, $0.5515 vs $2.64 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 87% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Tropicamide 10 mg/mL Solution/ 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 |
|---|---|---|---|---|---|---|
| Tropicamide 10 mg/mL 70069-0121-01 | Somerset | 1 bottle | $0.552 | AT | Availability likely | save 79% |
| Tropicamide 10 mg/mLthis 61314-0355-01 | Sandoz | 1 bottle | $2.635 | AT | Availability likely | — |
| Mydriacyl 10 mg/mL 00065-0355-03 | Alcon | 1 bottle | — | AT | FDA listed | — |
| Mydriacyl 10 mg/mL 00998-0355-15 | Alcon | 1 bottle | — | AT | FDA listed | — |
| Tropicamide 10 mg/mL 24208-0585-59 | Bausch | 1 bottle | — | AT | FDA listed | — |
| Tropicamide 10 mg/mL 85766-0040-15 | Sportpharm | 1 bottle | — | AT | FDA listed | — |
| Tropicamide 10 mg/mL 85766-0278-15 | Sportpharm | 1 bottle | — | AT | 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
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 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 QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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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 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 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.
6 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
- ZARXIO filgrastim-sndz 300 ug/.5mL Injection, Solution NDC 61314-318-01
- Adalimumab 80 mg/.8mL Injection, Solution NDC 61314-325-20
- ZARXIO filgrastim-sndz 480 ug/.8mL Injection, Solution NDC 61314-326-01
- Adalimumab 40 mg/.4mL Injection, Solution NDC 61314-327-20
- Adalimumab 20 mg/.2mL Injection, Solution NDC 61314-332-64
- Tropicamide 5 mg/mL Solution/ Drops NDC 61314-354-01
- Adalimumab 10 mg/.1mL Injection, Solution NDC 61314-391-64
- Cyclopentolate Hydrochloride 10 mg/mL Solution NDC 61314-396-01
- HYRIMOZ adalimumab-adaz 80 mg/.8mL Injection, Solution NDC 61314-454-20
- HYRIMOZ adalimumab-adaz 40 mg/.4mL Injection, Solution NDC 61314-473-20
- HYRIMOZ adalimumab-adaz 20 mg/.2mL Injection, Solution NDC 61314-476-64
- HYRIMOZ adalimumab-adaz 10 mg/.1mL Injection, Solution NDC 61314-509-64
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 For mydriasis and cycloplegia for diagnostic procedures.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION For refraction, instill one or two drops of 1% solution in the eye(s), repeated in five minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect. For examination of fundus, instill one or two drops of 0.5% solution 15 or 20 minutes prior to examination.
Individuals with heavily pigmented irides may require higher strength or more doses. Mydriasis will reverse spontaneously with time, typically in 4 to 8 hours. However, in some cases, complete recovery may take up to 24 hours.
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
⛔ Contraindications ▾
CONTRAINDICATIONS Contraindicated in persons showing hypersensitivity to any component of this preparation.
⚠️ Warnings ▾
WARNINGS For topical ophthalmic use only. Not for injection. This preparation may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergic drugs should be considered. Mydriatics may produce a transient elevation of intraocular pressure. Remove contact lenses before using.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Ocular: Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of tropicamide. Increased intraocular pressure has been reported following the use of mydriatics. Non-Ocular: Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.
Psychotic reactions, behavioral disturbances, and vasomotor or cardio-respiratory collapse in children have been reported with the use of anticholinergic drugs.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, dilating the pupil (mydriasis). The stronger preparation (1%) also paralyzes accommodation. This preparation acts in 15-30 minutes, and the duration of activity is approximately 3-8 hours.
Complete recovery from mydriasis in some individuals may require 24 hours. The weaker strength may be useful in producing mydriasis with only slight cycloplegia. Heavily pigmented irides may require more doses than lightly pigmented irides.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED 3mL and 15mL in plastic dispensers. 1% - 3 mL: NDC 61314-355-01 1% - 15 mL: NDC 61314-355-02 STORAGE: Store at 8° to 27°C (46° to 80°F). Do not refrigerate or store at high temperatures. Keep container tightly closed. Revised: 11-2021
📋 Description ▾
Rx Only DESCRIPTION Tropicamide Ophthalmic Solution, USP is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths. The active ingredient is represented by the chemical structure: Established name: Tropicamide ophthalmic solution Chemical name: Benzeneacetamide, N -ethyl-α-(hydroxymethyl)- N -(4-pyridinylmethyl)-. Each mL contains: Active: tropicamide 1%.
Preservative: benzalkonium chloride 0.01%. Inactives: sodium chloride, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water. pH 4.0 - 5.8. chemical
⚠️ Precautions ▾
PRECAUTIONS General: The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption. Information for Patients: Do not touch dropper tip to any surface, as this may contaminate the solution. Patient should be advised not to drive or engage in potentially hazardous activities while pupils are dilated.
Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration. Drug Interactions: Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
Carcinogenesis, Mutagenesis, Impairment of Fertility: There have been no long-term studies done using tropicamide in animals to evaluate carcinogenic potential. Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with tropicamide.
It is also not known whether tropicamide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tropicamide should be given to a pregnant woman only if clearly needed. Nursing Mothers: It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when tropicamide is administered to a nursing woman. Pediatric Use: Tropicamide may rarely cause CNS disturbances which may be dangerous in pediatric patients. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs (See WARNINGS ).
Keep this and all medications out of the reach of children. Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
📄 Package Label / Principal Display Panel ▾
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 61314-355-01 Tropicamide Ophthalmic Solution, USP 1% Rx only STERILE 3 mL SANDOZ A Novartis Division Side Panel: A Sterile Anticholinergic Agent Usual Dosage: One or two drops topically in the eye(s). Read enclosed insert. Precaution: Do not touch dropper tip to any surface, as this may contaminate the solution.
Storage: Store at 8° to 27°C (46° to 80°F). Do not refrigerate or store at high temperature. Keep container tightly closed.
Ingredients: Each mL contains: Active: tropicamide 1%. Preservative: benzalkonium chloride 0.01%. Inactives: sodium chloride, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water. pH 4.0 - 5.8.
Keep out of the reach of children. Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540 Product of Japan 9017187-0620 Rev.
06/2020 3ml-carton