Search by Drug Name or NDC

NDC 17478-0102-12 Tropicamide 10 mg/mL Details

Tropicamide 10 mg/mL

Tropicamide is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Akorn. The primary component is TROPICAMIDE.

Product Information

NDC	17478-0102
Product ID	17478-102_b8946687-fd16-4405-8320-85fdb1f8d68b
Associated GPIs	86350050002010
GCN Sequence Number	007873
GCN Sequence Number Description	tropicamide DROPS 1 % OPHTHALMIC
HIC3	Q6J
HIC3 Description	MYDRIATICS
GCN	33021
HICL Sequence Number	003466
HICL Sequence Number Description	TROPICAMIDE
Brand/Generic	Generic
Proprietary Name	Tropicamide
Proprietary Name Suffix	n/a
Non-Proprietary Name	Tropicamide
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	10
Active Ingredient Units	mg/mL
Substance Name	TROPICAMIDE
Labeler Name	Akorn
Pharmaceutical Class	Anticholinergic [EPC], Cholinergic Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA040315
Listing Certified Through	2023-12-31

Package

Package Images

NDC 17478-0102-12 (17478010212)

Pricing Information
NDC Package Code	17478-102-12
Billing NDC	17478010212
Package	1 BOTTLE, DROPPER in 1 CARTON (17478-102-12) / 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2000-09-29
NDC Exclude Flag	N
Price Per Unit	0.42973
Pricing Unit	ML
Effective Date	2022-05-18
NDC Description	TROPICAMIDE 1% EYE DROPS
Pharmacy Type Indicator	C/I
OTC	N
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2022-11-23

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 329a3382-3718-4311-890f-97c6b7e0077c Details

SPL UNCLASSIFIED SECTION

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 structural formula:

C17H20N2O2 MW=284.36

Established name: Tropicamide

Chemical name: Benzeneacetamide, N-ethyl-α-(hydroxymethyl)-N-(4-pyridinylmethyl)-.

Each mL contains: Active: Tropicamide 0.5% (5 mg) or 1% (10 mg). Inactives: Edetate Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH), Water for Injection. pH range 4.0 to 5.8. Preservative: Benzalkonium Chloride 0.01%.

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.

INDICATIONS AND USAGE:

For mydriasis and cycloplegia for diagnostic procedures.

CONTRAINDICATIONS:

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

WARNINGS:

For topical 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.

PRECAUTIONS:

General: The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to avoid 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.

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 mydri-atics.

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.

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 to 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.

HOW SUPPLIED:

Tropicamide Ophthalmic Solution USP, 0.5% and 1% are supplied as sterile solutions in plastic dropper bottles.

: 0.5% NDC 17478-101-12 (15 mL)
: 1% NDC 17478-102-12 (15 mL)
: 1% NDC 17478-102-20 (2 mL)

STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not refrigerate or store at high temperatures. Keep container tightly closed.

Akorn

Distributed by:

Akorn Operating Company LLC

Gurnee, IL 60031

TC00N Rev. 03/22

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-101-12

Tropicamide

Ophthalmic

Solution, USP

0.5%

Sterile

15 mL

Rx only

For Topical Ophthalmic Use Only

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 17478-101-12

Tropicamide

Ophthalmic

Solution, USP

0.5%

For Topical Ophthalmic

Use only.

Sterile

15 mL

Rx only [Akorn logo]

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-102-12

Tropicamide

Ophthalmic

Solution, USP

Sterile

15 mL

Rx only

For Topical Ophthalmic Use Only

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 17478-102-12

Tropicamide

Ophthalmic

Solution, USP

For Topical Ophthalmic

Use only.

Sterile

15 mL

Rx only [Akorn logo]

INGREDIENTS AND APPEARANCE

TROPICAMIDE

tropicamide solution/ drops

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:17478-102
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Tropicamide (UNII: N0A3Z5XTC6) (Tropicamide - UNII:N0A3Z5XTC6)	Tropicamide	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
benzalkonium chloride (UNII: F5UM2KM3W7)
edetate disodium (UNII: 7FLD91C86K)
sodium chloride (UNII: 451W47IQ8X)
sodium hydroxide (UNII: 55X04QC32I)
hydrochloric acid (UNII: QTT17582CB)
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:17478-102-12	1 in 1 CARTON	09/29/2000
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC:17478-102-20	1 in 1 CARTON	09/29/2000	05/18/2022
2		2 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040315	09/29/2000

TROPICAMIDE

tropicamide solution/ drops

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:17478-101
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Tropicamide (UNII: N0A3Z5XTC6) (Tropicamide - UNII:N0A3Z5XTC6)	Tropicamide	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
benzalkonium chloride (UNII: F5UM2KM3W7)
edetate disodium (UNII: 7FLD91C86K)
sodium chloride (UNII: 451W47IQ8X)
sodium hydroxide (UNII: 55X04QC32I)
hydrochloric acid (UNII: QTT17582CB)
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17478-101-12	1 in 1 CARTON	09/29/2000
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040314	09/29/2000

Labeler - Akorn (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn		117696832	MANUFACTURE(17478-102, 17478-101) , ANALYSIS(17478-102, 17478-101) , STERILIZE(17478-102, 17478-101)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn		117696790	PACK(17478-102, 17478-101) , LABEL(17478-102, 17478-101)

Revised: 7/2022

Document Id: b8946687-fd16-4405-8320-85fdb1f8d68b

Set id: 329a3382-3718-4311-890f-97c6b7e0077c

Version: 8

Effective Time: 20220701

Search by Drug Name or NDC

NDC 17478-0102-12 Tropicamide 10 mg/mL Details

Tropicamide 10 mg/mL

Product Information

Package

Package Images

NDC 17478-0102-12 (17478010212)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 329a3382-3718-4311-890f-97c6b7e0077c Details

SPL UNCLASSIFIED SECTION

DESCRIPTION:

CLINICAL PHARMACOLOGY:

INDICATIONS AND USAGE:

CONTRAINDICATIONS:

WARNINGS:

PRECAUTIONS:

ADVERSE REACTIONS:

DOSAGE AND ADMINISTRATION:

HOW SUPPLIED:

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Migranal Generic Name Question

Can You Take A Z-Pak If You Have A Penicillin Allergy?