FDA.reportPublic FDA data

NDC 0409-4910-11 - Atropine Sulfate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0409-4910
Requested NDC
0409-4910-11
Package NDCs from labels
0409-4910-11, 0409-4910-34
Manufacturer
Hospira, Inc.
Effective date
2026-05-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Atropine Sulfate - Hospira, Inc.Hospira, Inc.2026-05-18HUMAN PRESCRIPTION DRUG LABEL
Atropine Sulfate - Henry Schein, Inc.Henry Schein, Inc.2024-10-14HUMAN PRESCRIPTION DRUG LABEL
ATROPINE SULFATE INJECTION, USP 0.5mg (0.1 mg/mL) SYR, 5mLHF Acquisition Co., LLC, DBA Health First | HF Acquisition Co. LLC, DBA Health First2024-01-25HUMAN PRESCRIPTION DRUG LABEL
Atropine Sulfate - General Injectables & Vaccines, Inc.General Injectables & Vaccines, Inc.2022-12-09HUMAN PRESCRIPTION DRUG LABEL
Model AA-8565CV-ACT Model AA-8565CV - Aerospace Accessory Service, IncAerospace Accessory Service, Inc2021-05-18MEDICAL DEVICE
Sodium Chloride - Aerospace Accessory Service, IncAerospace Accessory Service, Inc2021-05-18MEDICAL DEVICE
ATROPINE SULFATE - Hospira, Inc.Hospira, Inc.2020-04-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4910-11Atropine Sulfate5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION531
0409-4910-34Atropine Sulfate10 in 1 PACKAGEINJECTION, SOLUTION1031
0409-4910-34Atropine Sulfate1 in 1 CARTONINJECTION, SOLUTION131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4910ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]27Legacy NDC, 3 package rows20250124_ad8916e7-206e-409e-2582-30d072845dd4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4910-11ML - Milliliter0409-49107b5e99cd-591d-4ac6-9d42-17208892e0a112019-08-06
0409-4910-34ML - Milliliter0409-49106f6db159-a625-416c-a441-a51831573efe12013-02-13

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
Atropine SulfateACTIVE INGREDIENT03J5ZE7KA5ATROPINE SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.]3
AtropineACTIVE MOIETY7C0697DR9IATROPINE SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.]3
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XATROPINE SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.]3
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1
ATROPINEACTIVE MOIETY7C0697DR9IATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1

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 2 of 763 · 15,260 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Free Foaming Hand SanitizerBENZALKONIUM CHLORIDEBetco Corporation, Ltd.7e038b0a-4813-4f4b-ad66-0584d75a064f2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9a9fc7c-31da-ea3f-e053-2a95a90a0eab2026-09-09WarningsExact identifier
application number: M003
unii: F5UM2KM3W7
unii: V13007Z41A
Ultra Blue Antibacterial Foaming Skin CleanserBENZALKONIUM CHLORIDEBetco Corporation, Ltdaa8f5b05-882d-d05a-e053-2995a90abaea2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Burn GelLIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9d3e9be-1036-fad0-e053-2a95a90a6efe2026-09-09WarningsExact identifier
unii: V13007Z41A
Touchland Glow Mist Hand Sanitizer RosewaterALCOHOLChurch & Dwight Co., Inc.5a850866-bc5d-e595-e063-6394a90a335f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDIRECT RXbae9c9c1-107f-0fcb-e053-2a95a90a75b22026-09-09Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
nitroglycerinNITROGLYCERINMedical Purchasing Solutions, LLC.5b150cd2-fac8-86ce-e063-6294a90a67b92026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 198039
unii: G59M7S0WS3
Low Dose AspirinASPIRINStrategic Sourcing Services LLC7ce4807e-7bd5-41f1-a9c7-1f3af6acdc092026-09-09WarningsExact identifier
unii: R16CO5Y76E
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
unii: 451W47IQ8X
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
unii: 362O9ITL9D
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.8cf6943f-16e8-4521-863c-09bb0b55e2a92026-09-09Warnings, Adverse reactionsExact identifier
application number: NDA019445
rxcui: 727517
unii: LX22YL083G
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Extra StrengthACETAMINOPHENWal-Mart Stores Inc78874258-16cc-40b5-9e15-5943eddfce942026-09-08WarningsExact identifier
unii: 362O9ITL9D
SORE THROATPHENOLRaritan Pharmaceuticals Inc43ce374a-824c-4034-bf04-c351b4d8015b2026-09-08WarningsExact identifier
unii: 339NCG44TV
Alcohol Prep Pad MediumALCOHOL PREP PADYangzhou Huanrui Medical Technology Co., Ltd5af3eedc-d01e-c9e9-e063-6394a90a49e12026-09-08WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
RectivNITROGLYCERINAllergan, Inc.603aa9ed-54c4-4a35-ade4-690fa44850e42026-09-08Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5af9f31b-0c92-e3a9-e063-6394a90a38c92026-09-08WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.