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Tropicamide 10 mg/mL Solution/ Drops — NDC 24208-0585-59 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tropicamide 10 mg/mL Solution/ Drops — NDC 24208-585-59 (Billing 24208-0585-59)

by Bausch & Lomb Incorporated · 1 BOTTLE, DROPPER in 1 CARTON / 2 mL in 1 BOTTLE, DROPPER

This is a package of Tropicamide 10 mg/mL Solution/ Drops from Bausch & Lomb Incorporated, marketed since Jul 1994 and currently FDA-listed.

NDC 24208-0585-59
🏷️ FDA NDC (as labeled) 24208-585-59 billing pads the product segment with a zero
This package
Contains2 mL in 1 bottle, dropper Pack sizes2 compare ↓
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 24208-585-59 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
24208 labeler · 585 product · 59 package
Package marketed since
Jul 27, 1994
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 2420858559 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 24208-585-59
Product NDC 24208-585
11-digit billing NDC 24208058559
NCPDP billing unit ML — per mL (volume)
RxCUI 313521, 314238
UNII N0A3Z5XTC6
Application # ANDA040064
SPL Set ID 892b78c8-36bc-47d3-850e-502899b48fb9
Established class (EPC) Anticholinergic
Mechanism of action Cholinergic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1994-07-27
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance TROPICAMIDE
TE code (Orange Book) AT · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 86350050002010
GPI class Tropicamide
GCN Seq No 007873
GCN 33021
HICL code 003466
Ingredient (HICL) Tropicamide
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6J
Therapeutic class — specific (HIC3) Mydriatics
AHFS code 52:24.00.00
AHFS class Mydriatics
FDB label name TROPICAMIDE 1% EYE DROPS
FDB brand name Tropicamide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • 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): 313521
Why two NDCs? The FDA registers this code as 24208-585-59 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 24208-0585-59. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Anticholinergic class.

Pharmacologic class Anticholinergic
Drug family (ATC) Anticholinergics
How it works Cholinergic Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name TROPICAMIDE 1% EYE DROPS Ingredient Tropicamide
📖 What it is MedlinePlus · NLM

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 ↗
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 15 mL
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
24208-0585-59 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON / 2 mL in 1 BOTTLE, DROPPER — — 1994-07-27 — Active
24208-0585-64 24208-585-64 Main listing 1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER $0.5515 / mL $8.27 1994-07-27 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, dropper in 1 carton / 2 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Tropicamide 10 mg/mL Solution/ Drops?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tropicamide 10 mg/mL 70069-0121-01 Somerset 1 bottle $0.552 AT Availability likely —
Tropicamide 10 mg/mL 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/mLthis 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 —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1994
On the market since
Jul 1994
📍
2026
Currently FDA-listed
32 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBausch & Lomb Incorporated
Application holderBAUSCH AND LOMB INC
FDA applicationANDA040064 (ANDA)
Labeler code24208
First marketedJul 1994
Product typeHuman Prescription Drug
Portfolio92 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 10 words ▾

INDICATIONS AND USAGE For mydriasis and cycloplegia for diagnostic procedures.

⏱️ Dosage and Administration 95 words ▾

DOSAGE AND ADMINISTRATION For refraction, one or two drops of the 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, one or two drops of the 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.

⛔ Contraindications 12 words ▾

CONTRAINDICATIONS Contraindicated in persons showing hypersensitivity to any component of this preparation.

⚠️ Warnings 53 words ▾

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 reaction and behavioral disturbance 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 96 words ▾

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 cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 16 words ▾

Drug Interactions Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

🤰 Pregnancy 44 words ▾

Pregnancy 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.

🧒 Pediatric Use 49 words ▾

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 17 words ▾

Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

🧬 Clinical Pharmacology 84 words ▾

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 (0.5%) 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 148 words ▾

HOW SUPPLIED Tropicamide ophthalmic solution USP, 1% is supplied in a plastic bottle with a red cap and a controlled drop tip in the following sizes: NDC 24208-585-59: 2 mL in a 7.5 mL bottle NDC 24208-585-64: 15 mL in a 15 mL bottle Tropicamide ophthalmic solution USP, 0.5% is supplied in a plastic bottle with a red cap and a controlled drop tip in the following size: NDC 24208-590-64: 15 mL in a 15 mL bottle Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Keep container tightly closed. Keep out of reach of children. Distributed by: Bausch & Lomb Americas Inc.

Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Revised: September 2023 9115807 (Folded) 9115907 (Flat) donotuse

📋 Description 75 words ▾

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 following chemical structure: Chemical name: Benzeneacetamide, N -ethyl-α-(hydroxymethyl)- N -(4-pyridinylmethyl)- Each mL contains: Active: tropicamide 5 mg (0.5%) or 10 mg (1%); Inactives: boric acid, hydrochloric acid, edetate disodium dihydrate, purified water. Sodium hydroxide and/or hydrochloric acid (to adjust pH) pH range 4.0 - 5.8.

Preservative: benzalkonium chloride 0.01%. ChemStructure-Tropicamide.jpg

💬 Information for Patients 73 words ▾

Information for Patients Do not touch dropper tip to any surface, as this may contaminate the solution. Patients should be advised not to drive or engage in potentially hazardous activities while pupils are dilated. Patients 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 wash their own hands and the child’s hands following administration.

🍼 Nursing Mothers 34 words ▾

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.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 20 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility There have been no long-term studies done using tropicamide in animals to evaluate carcinogenic potential.

📄 Package Label / Principal Display Panel 61 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL (Mexico) -

0.5NDC 24208-590-64 Tropicamide Ophthalmic Solution, USP 0.5% (Sterile) FOR TOPICAL OPHTHALMIC USE ONLY Rx only 15 mL BAUSCH + LOMB 9052002 AB07311 carton-mexico 0.5 15ml

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Mexico 1 NDC 24208-585-64 Tropicamide Ophthalmic Solution, USP 1% (Sterile) FOR TOPICAL OPHTHALMIC USE ONLY Rx only 15 mL BAUSCH + LOMB 9173402 AB07411 carton-mexico1.015ml

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle24208-0585-64 142 Rx · $2,357
Drug total (last 4 qtrs): 142 Rx · 2,037 units · $2,357 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Tropicamide — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Tropicamide. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.3K
Claims incl. refills
200
Beneficiaries
197
Spend / beneficiary
$11.61
Spend / claim
$11.43
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
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 ✓ Available
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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bausch & Lomb Incorporated. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (24208-0585-64). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Bausch & Lomb Incorporated is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.