FDA.reportPublic FDA data

Atropine Sulfate

Product NDC
0409-4911
11-digit product format
004094911
Labeler code
0409
Product ID
0409-4911_77d2cecb-001f-4b7b-b8ee-94c8b6d89be5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATROPINE SULFATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA021146
Marketing category
NDA
Marketing start
2005-10-25
Marketing end
0000-00-00
Substance
ATROPINE SULFATE
Active strength
0 mg/mL
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4911-11Atropine Sulfate10 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION1031
0409-4911-34Atropine Sulfate10 in 1 PACKAGEINJECTION, SOLUTION1031
0409-4911-34Atropine Sulfate1 in 1 CARTONINJECTION, SOLUTION131

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4911-11ML - Milliliter0409-491110ed536d-53eb-4928-bb93-ec3e0d9634ff12019-08-06
0409-4911-34ML - Milliliter0409-4911d865d899-26ee-422a-b9e8-2019843ecf3312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]11
ATROPINEACTIVE MOIETY7C0697DR9IATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]11
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]11
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]11
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]11
WATERINACTIVE INGREDIENT059QF0KO0RATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4911ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]27Legacy NDC, 3 package rows20250124_ad8916e7-206e-409e-2582-30d072845dd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190551atropine sulfate 0.25 MG in 5 ML Prefilled SyringePSNad8916e7-206e-409e-2582-30d072845dd431
1190552atropine sulfate 0.5 MG in 5 ML Prefilled SyringePSNad8916e7-206e-409e-2582-30d072845dd431
1190546atropine sulfate 1 MG in 10 ML Prefilled SyringePSNad8916e7-206e-409e-2582-30d072845dd431
119054610 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCDad8916e7-206e-409e-2582-30d072845dd431
11905515 ML atropine sulfate 0.05 MG/ML Prefilled SyringeSCDad8916e7-206e-409e-2582-30d072845dd431
11905525 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCDad8916e7-206e-409e-2582-30d072845dd431
1190551atropine sulfate 0.25 MG per 5 ML Prefilled SyringeSYad8916e7-206e-409e-2582-30d072845dd431
1190552atropine sulfate 0.5 MG per 5 ML Prefilled SyringeSYad8916e7-206e-409e-2582-30d072845dd431
1190546atropine sulfate 1 MG per 10 ML Prefilled SyringeSYad8916e7-206e-409e-2582-30d072845dd431
1190552atropine sulfate 500 MCG per 5 ML Prefilled SyringeSYad8916e7-206e-409e-2582-30d072845dd431
1190546atropine sulfate 1 MG in 10 ML Prefilled SyringePSN74106ef7-83bf-47ba-e053-2991aa0aaec110
119054610 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCD74106ef7-83bf-47ba-e053-2991aa0aaec110
1190546atropine sulfate 1 MG per 10 ML Prefilled SyringeSY74106ef7-83bf-47ba-e053-2991aa0aaec110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-4911-110040949111110 mL in 1 SYRINGE, GLASS10 mlHistorical
0409-4911-340040949113410 CARTON in 1 PACKAGE (0409-4911-34) > 1 SYRINGE, GLASS in 1 CARTON > 10 mL in 1 SYRINGE, GLASS (0409-4911-11) 10 carton2005-10-250000-00-00NoNoCurrent