FDA.reportPublic FDA data

5 ML atropine sulfate 0.05 MG/ML Prefilled Syringe

RxCUI
1190551
RxNorm name
5 ML atropine sulfate 0.05 MG/ML Prefilled Syringe
Display name
Atropine (Injectable)
Full name
5 ML atropine sulfate 0.05 MG/ML Prefilled Syringe
Term type
SCD
Status
Active
Strength
0.25 mg/5ml
Dose form
Prefilled Syringe 5 ml
Route
Injectable
Updated
2026-08-03 17:32:09

RxNorm Status History#

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

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
atropine sulfate0.05 MG / 1 MLatropineatropine sulfate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Prefilled Syringe721656

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
atropine1223

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STR5 ML atropine sulfate 0.05 MG/ML Prefilled Syringe1NAMES
RxNorm Name5 ML atropine sulfate 0.05 MG/ML Prefilled Syringe1NAMES
RxNorm Synonymatropine sulfate 0.25 MG per 5 ML Prefilled Syringe1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI11905511CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0404-9823-050404-9823Atropine Sulfate Atropine SulfateHenry Schein, Inc.NDA021146
0409-9630-050409-9630Atropine Sulfate ATROPINE SULFATEHospira, Inc.NDA021146
16729-483-0316729-483ATROPINE SULFATE ATROPINE SULFATEAccord Healthcare, Inc.,ANDA212868
16729-483-3116729-483ATROPINE SULFATE ATROPINE SULFATEAccord Healthcare, Inc.,ANDA212868

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA0211460404-9823Atropine Sulfate Atropine SulfateNDAHenry Schein, Inc.
ANDA21286816729-483ATROPINE SULFATE ATROPINE SULFATEANDAAccord Healthcare, Inc.,

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 9 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00404982305rxnav_ndcsyes
00409963005rxnav_ndcsyes
00409963015rxnav_ndcsyes
16729048303rxnav_ndcsyes
16729048331rxnav_ndcsyes
00074789701rxnav_historical_indirect
00074789715rxnav_historical_indirect
00074963005rxnav_historical_indirect
52584063005rxnav_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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atropine SulfateATROPINE SULFATEHospira, Inc.ad8916e7-206e-409e-2582-30d072845dd42026-05-18Warnings, Adverse reactionsExact identifier
ndc (package): 0409-9630-05
ndc (product): 0409-9630
ndc11 (package): 00409963015
ndc11 (package): 00409963005
rxcui: 1190551
ATROPINE SULFATEATROPINE SULFATEAccord Healthcare, Inc.,c82cb295-ffce-47d6-97ad-a8aa723f4e4f2025-10-06Warnings, Adverse reactionsExact identifier
ndc (package): 16729-483-03
ndc (package): 16729-483-31
ndc (product): 16729-483
ndc11 (package): 16729048331
ndc11 (package): 16729048303
rxcui: 1190551
Atropine SulfateATROPINE SULFATEHenry Schein, Inc.d4839e54-b350-4643-8e6e-f0437f5349d62025-04-17Warnings, Adverse reactionsExact identifier
ndc (package): 0404-9823-05
ndc (product): 0404-9823
ndc11 (package): 00404982305
rxcui: 1190551

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ad8916e7-206e-409e-2582-30d072845dd4atropine sulfate 0.25 MG in 5 ML Prefilled Syringe [PSN] · 5 ML atropine sulfate 0.05 MG/ML Prefilled Syringe [SCD] · atropine sulfate 0.25 MG per 5 ML Prefilled Syringe [SY]331These highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively. See full prescribing information for ATROPINE SULFATE INJECTION. ATROPINE SULFATE injection, for intravenous use Initial U.S. Approval: 196020260518
c82cb295-ffce-47d6-97ad-a8aa723f4e4fatropine sulfate 0.25 MG in 5 ML Prefilled Syringe [PSN] · 5 ML atropine sulfate 0.05 MG/ML Prefilled Syringe [SCD] · atropine sulfate 0.25 MG per 5 ML Prefilled Syringe [SY]39These highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively. See full prescribing information for ATROPINE SULFATE INJECTION. ATROPINE SULFATE injection, for intravenous use Initial U.S. Approval: 196020251006
d4839e54-b350-4643-8e6e-f0437f5349d6atropine sulfate 0.25 MG in 5 ML Prefilled Syringe [PSN] · 5 ML atropine sulfate 0.05 MG/ML Prefilled Syringe [SCD] · atropine sulfate 0.25 MG per 5 ML Prefilled Syringe [SY]37These highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively. See full prescribing information for ATROPINE SULFATE INJECTION. ATROPINE SULFATE INJECTION, for intravenous use Initial U.S. Approval: 196020250417

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
ad8916e7-206e-409e-2582-30d072845dd4These highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively. See full prescribing information for ATROPINE SULFATE INJECTION. ATROPINE SULFATE injection, for intravenous use Initial U.S. Approval: 1960Hospira, Inc.20260518
ad8916e7-206e-409e-2582-30d072845dd4These highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively. See full prescribing information for ATROPINE SULFATE INJECTION. ATROPINE SULFATE injection, for intravenous use Initial U.S. Approval: 1960Hospira, Inc.20251112
c82cb295-ffce-47d6-97ad-a8aa723f4e4fThese highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively. See full prescribing information for ATROPINE SULFATE INJECTION. ATROPINE SULFATE injection, for intravenous use Initial U.S. Approval: 1960Accord Healthcare, Inc., | Intas Pharmaceuticals Limited20251006
ad8916e7-206e-409e-2582-30d072845dd4These highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively. See full prescribing information for ATROPINE SULFATE INJECTION. ATROPINE SULFATE injection, for intravenous use Initial U.S. Approval: 1960Hospira, Inc.20250915
d4839e54-b350-4643-8e6e-f0437f5349d6These highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively. See full prescribing information for ATROPINE SULFATE INJECTION. ATROPINE SULFATE INJECTION, for intravenous use Initial U.S. Approval: 1960Henry Schein, Inc.20250417
c82cb295-ffce-47d6-97ad-a8aa723f4e4fThese highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively. See full prescribing information for ATROPINE SULFATE INJECTION. ATROPINE SULFATE injection, for intravenous use Initial U.S. Approval: 1960Accord Healthcare, Inc., | Intas Pharmaceuticals Limited20241120
b1fe2ec1-8604-45ea-8b45-15f01c9fe309Pediatric Atropine Sulfate, Injection USP 0.25mg/5ml HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively. See full prescribing information for ATROPINE SULFATE INJECTION. ATROPINE SULFATE INJECTION, for intravenous, intramuscular, subcutaneous or endotracheal use. Initial U.S. Approval: 1960General Injectables & Vaccines, Inc.20221209
13a00c17-1ee1-4b4f-9260-66efb5418b98National Council for Prescription Drug Programs20120724

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_STRENGTH0.05 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY5 ML
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA212868
CODESNDANDA021146
CODESVUID4000635
CODESVUID4042177
NAMESPrescribable Synonymatropine sulfate 0.25 MG in 5 ML Prefilled Syringe
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File