FDA.reportPublic FDA data

Atropine Sulfate

Product NDC
0404-9989
11-digit product format
004049989
Labeler code
0404
Product ID
0404-9989_edaf1d42-c2af-4369-8d75-b3a93d70d390
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
NDA214652
Marketing category
NDA
Marketing start
2023-09-05
Substance
ATROPINE SULFATE
Active strength
1 mg/mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atropine Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE SULFATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii03J5ZE7KA5
Rxcui1190795

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
0404-9989-01Atropine Sulfate1 in 1 BAGINJECTION, SOLUTION13
0404-9989-01Atropine Sulfate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9989ATROPINE SULFATE INJECTION, SOLUTION [HENRY SCHEIN, INC.]3Current NDC, 2 package rows20250119_4a9559e8-7a34-4509-a8cc-ff0125694539.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190795atropine sulfate 1 MG in 1 ML InjectionPSN4a9559e8-7a34-4509-a8cc-ff01256945393
11907951 ML atropine sulfate 1 MG/ML InjectionSCD4a9559e8-7a34-4509-a8cc-ff01256945393
1190795atropine sulfate 1 MG per 1 ML InjectionSY4a9559e8-7a34-4509-a8cc-ff01256945393

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0404-9989-01004049989011 VIAL, SINGLE-DOSE in 1 BAG (0404-9989-01) / 1 mL in 1 VIAL, SINGLE-DOSE2023-09-12NoNoHistorical