Tropicamide
Sandoz Inc
Human Prescription Drug
NDC 61314-354Tropicamide is a human prescription drug labeled by 'Sandoz Inc'. National Drug Code (NDC) number for Tropicamide is 61314-354. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Tropicamide drug includes Tropicamide - 5 mg/mL . The currest status of Tropicamide drug is Active.
Drug Information:
| Drug NDC: | 61314-354 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Tropicamide |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Tropicamide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Sandoz Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution/ Drops |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | TROPICAMIDE - 5 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | OPHTHALMIC
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 09 Jun, 2000 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA084305 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Sandoz Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 313521
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000175574
N0000175370
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | N0A3Z5XTC6
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Cholinergic Antagonists [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Anticholinergic [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class: | Anticholinergic [EPC]
Cholinergic Antagonists [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 61314-354-01 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-354-01) / 15 mL in 1 BOTTLE, PLASTIC | 09 Jun, 2000 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Tropicamide tropicamide tropicamide tropicamide benzalkonium chloride sodium chloride edetate disodium hydrochloric acid sodium hydroxide water
Drug Interactions:
Drug interactions tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
Indications and Usage:
Indications and usage for mydriasis and cycloplegia for diagnostic procedures.
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.
General Precautions:
General the lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption.
Dosage and Administration:
Dosage and administration 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.
Contraindications:
Contraindications contraindicated in persons showing hypersensitivity to any component of this preparation.
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. 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.
Drug Interactions:
Drug interactions tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
Use in Pregnancy:
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:
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:
Geriatric use no overall differences in safety or effectiveness have been observed between elderly and younger patients.
Description:
Rx only description tropicamide ophthalmic solution, usp, 0.5% is an anticholinergic prepared as a sterile topical ophthalmic solution. 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 0.5%. 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
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 to 30 minutes, and the duration of activity is approximately 3 to 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.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility there have been no long-term studies done using tropicamide in animals to evaluate carcinogenic potential.
How Supplied:
How supplied tropicamide ophthalmic solution, usp, 0.5% is supplied in an ldpe plastic bottle with a dropper tip as: ndc 61314-354-01 15ml storage store at 8° to 25°c (46° to 77°f). do not refrigerate or store at high temperatures. keep container tightly closed. after opening, this product can be used until the expiration date on the bottle.
Information for Patients:
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.
Package Label Principal Display Panel:
Package/label principal display panel ndc 61314-354-01 tropicamide ophthalmic solution, usp 0.5% rx only sterile 15 ml sandoz carton