FDA.reportPublic FDA data

atropine sulfate 10 MG/ML Ophthalmic Solution [Isopto Atropine]

RxCUI
1190664
RxNorm name
atropine sulfate 10 MG/ML Ophthalmic Solution [Isopto Atropine]
Display name
ISOPTO ATROPINE (Ophthalmic)
Full name
atropine sulfate 10 MG/ML Ophthalmic Solution [Isopto Atropine]
Term type
SBD
Status
Active
Strength
1%
Dose form
Sol
Route
Ophthalmic
Updated
2026-08-08 11:33:54

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
112011
Active start
112011
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
atropine sulfate10 MG / 1 MLatropineatropine sulfate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Ophthalmic Solution7670

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
atropine1223

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRIsopto Atropine 1 % Ophthalmic Solution1NAMES
RxNorm Nameatropine sulfate 10 MG/ML Ophthalmic Solution [Isopto Atropine]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID20491566-e6eb-8d4a-3083-77ea429f7bc41CODES
RxCUI11906641CODES
MMSL_CODEBD5871CODES

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 5 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00065030355rxnav_ndcsyes
00065030306rxnav_historical
00065030315rxnav_historical
00998030305rxnav_historical
00998030315rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopto AtropineATROPINE SULFATEAlcon Laboratories, Inc.20491566-e6eb-8d4a-3083-77ea429f7bc42022-10-07Warnings, Adverse reactionsExact identifier
ndc11 (package): 00065030355
rxcui: 1190664

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
20491566-e6eb-8d4a-3083-77ea429f7bc4Isopto Atropine 1 % Ophthalmic Solution [PSN] · atropine sulfate 10 MG/ML Ophthalmic Solution [Isopto Atropine] [SBD] · Isopto Atropine 1 % Ophthalmic Solution [SY] · Isopto Atropine 10 MG/ML Ophthalmic Solution [SY]48These highlights do not include all the information needed to use ISOPTO® ATROPINE safely and effectively. See full prescribing information for ISOPTO® ATROPINE ISOPTO® ATROPINE (atropine sulfate ophthalmic solution) 1%, for topical ophthalmic use Initial U.S. Approval: 196020221007

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
20491566-e6eb-8d4a-3083-77ea429f7bc4These highlights do not include all the information needed to use ISOPTO® ATROPINE safely and effectively. See full prescribing information for ISOPTO® ATROPINE ISOPTO® ATROPINE (atropine sulfate ophthalmic solution) 1%, for topical ophthalmic use Initial U.S. Approval: 1960Alcon Laboratories, Inc. | Boehringer Ingelheim Pharma GmbH & Co. KG20221007
0f7ccc3f-1472-4636-b127-a54987f7a828National Council for Prescription Drug Programs20130213
468e72ca-9053-467b-83ef-714ae7fe1298National Council for Prescription Drug Programs20130213

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCS01FAAnticholinergicsATC1-4atropine
ATCA03BABelladonna alkaloids, tertiary aminesATC1-4atropine
FDASPLN0000175574AnticholinergicEPChas_epcatropine
FDASPLN0000175700Cholinergic Muscarinic AntagonistEPChas_epcatropine
FDASPLN0000175370Cholinergic AntagonistsMOAhas_moaatropine
FDASPLN0000000125Cholinergic Muscarinic AntagonistsMOAhas_moaatropine
MEDRTD001285AtropineCHEMhas_ingredientatropine
MEDRTD001285AtropineCHEMhas_ingredientatropine sulfate
MEDRTD001249AsthmaDISEASEci_withatropine
MEDRTD001249AsthmaDISEASEci_withatropine sulfate
MEDRTD001919BradycardiaDISEASEmay_treatatropine
MEDRTD001919BradycardiaDISEASEmay_treatatropine sulfate
MEDRTD003093Colitis, UlcerativeDISEASEci_withatropine
MEDRTD003093Colitis, UlcerativeDISEASEci_withatropine sulfate
MEDRTD004342Drug HypersensitivityDISEASEci_withatropine
MEDRTD004342Drug HypersensitivityDISEASEci_withatropine sulfate
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatatropine
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatatropine sulfate
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withatropine
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withatropine sulfate
MEDRTD006323Heart ArrestDISEASEmay_treatatropine
MEDRTD006323Heart ArrestDISEASEmay_treatatropine sulfate
MEDRTD006327Heart BlockDISEASEci_withatropine sulfate
MEDRTD006327Heart BlockDISEASEci_withatropine
MEDRTD007415Intestinal ObstructionDISEASEci_withatropine
MEDRTD007415Intestinal ObstructionDISEASEci_withatropine sulfate
MEDRTD007499Iris DiseasesDISEASEci_withatropine
MEDRTD007499Iris DiseasesDISEASEci_withatropine sulfate
MEDRTD007674Kidney DiseasesDISEASEci_withatropine sulfate
MEDRTD007674Kidney DiseasesDISEASEci_withatropine
MEDRTD007905Lens DiseasesDISEASEci_withatropine sulfate
MEDRTD007905Lens DiseasesDISEASEci_withatropine
MEDRTD008107Liver DiseasesDISEASEci_withatropine sulfate
MEDRTD008107Liver DiseasesDISEASEci_withatropine
MEDRTD008532Megacolon, ToxicDISEASEci_withatropine sulfate
MEDRTD008532Megacolon, ToxicDISEASEci_withatropine
MEDRTD009157Myasthenia GravisDISEASEci_withatropine sulfate
MEDRTD009157Myasthenia GravisDISEASEci_withatropine
MEDRTD015878MydriasisDISEASEinducesatropine
MEDRTD015878MydriasisDISEASEinducesatropine sulfate
MEDRTD011041PoisoningDISEASEmay_treatatropine sulfate
MEDRTD011041PoisoningDISEASEmay_treatatropine
MEDRTD012848Sinoatrial BlockDISEASEmay_treatatropine sulfate
MEDRTD012848Sinoatrial BlockDISEASEmay_treatatropine
MEDRTD013276Stomach UlcerDISEASEmay_treatatropine sulfate
MEDRTD013276Stomach UlcerDISEASEmay_treatatropine
MEDRTD013610TachycardiaDISEASEci_withatropine sulfate
MEDRTD013610TachycardiaDISEASEci_withatropine
MEDRTD013971ThyrotoxicosisDISEASEci_withatropine
MEDRTD013971ThyrotoxicosisDISEASEci_withatropine sulfate
MEDRTD000267Tissue AdhesionsDISEASEci_withatropine
MEDRTD000267Tissue AdhesionsDISEASEci_withatropine sulfate
MEDRTD014517Ureteral ObstructionDISEASEci_withatropine
MEDRTD014517Ureteral ObstructionDISEASEci_withatropine sulfate
MEDRTD014605UveitisDISEASEmay_treatatropine
MEDRTD014605UveitisDISEASEmay_treatatropine sulfate
MEDRTD014987XerostomiaDISEASEinducesatropine sulfate
MEDRTD014987XerostomiaDISEASEinducesatropine
MEDRTN0000000125Cholinergic Muscarinic AntagonistsMOAhas_moaatropine
MEDRTN0000000125Cholinergic Muscarinic AntagonistsMOAhas_moaatropine sulfate
MEDRTN0000008779Decreased Parasympathetic Acetylcholine ActivityPEhas_peatropine
MEDRTN0000008779Decreased Parasympathetic Acetylcholine ActivityPEhas_peatropine sulfate
MEDRTN0000008868Decreased Respiratory SecretionsPEhas_peatropine
MEDRTN0000008868Decreased Respiratory SecretionsPEhas_peatropine sulfate
MEDRTN0000009808Positive ChronotropyPEhas_peatropine
MEDRTN0000009808Positive ChronotropyPEhas_peatropine sulfate
MEDRTN0000009820Pupillary DilationPEhas_peatropine
MEDRTN0000009820Pupillary DilationPEhas_peatropine sulfate
MEDRTN0000009842Salivation InhibitionPEhas_peatropine sulfate
MEDRTN0000009842Salivation InhibitionPEhas_peatropine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH10 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
CODESNDANDA208151
NAMESPrescribable SynonymIsopto Atropine 1 % Ophthalmic Solution
SOURCESSourceMetathesaurus FDA Structured Product Labels