FDA.reportPublic FDA data

ATROPINE SULFATE

Product NDC
71872-7298
11-digit product format
718727298
Labeler code
71872
Product ID
71872-7298_fa1c8b84-5f06-0df2-e053-6294a90abc11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATROPINE SULFATE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA212868
Marketing category
ANDA
Marketing start
2021-07-30
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 SULFATE.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii03J5ZE7KA5
Rxcui1190546

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
71872-7298-1ATROPINE SULFATE10 mL in 1 SYRINGE, GLASSINJECTION101
71872-7298-1ATROPINE SULFATE1 in 1 BAGINJECTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7298ATROPINE SULFATE INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC]1Current NDC, 2 package rows20230425_fa1c953b-723b-1abe-e053-6394a90a967f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190546atropine sulfate 1 MG in 10 ML Prefilled SyringePSNfa1c953b-723b-1abe-e053-6394a90a967f1
119054610 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCDfa1c953b-723b-1abe-e053-6394a90a967f1
1190546atropine sulfate 1 MG per 10 ML Prefilled SyringeSYfa1c953b-723b-1abe-e053-6394a90a967f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71872-7298-1718727298011 SYRINGE, GLASS in 1 BAG (71872-7298-1) / 10 mL in 1 SYRINGE, GLASS2022-08-08NoNoCurrent