Atropine Sulfate

Product NDC
70518-3120
11-digit product format
705183120
Labeler code
70518
Product ID
70518-3120_4e91c574-0f7d-506b-e063-6394a90abc3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA212461
Marketing category
ANDA
Marketing start
2021-06-14
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atropine Sulfate
Listing expiration
2027-12-31

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
70518-3120-0Atropine Sulfate10 in 1 PACKAGEINJECTION106
70518-3120-0Atropine Sulfate1 in 1 CARTONINJECTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3120ATROPINE SULFATE INJECTION [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 2 package rows20240314_46ba6000-b842-449a-8dd4-7bb9dc7a74c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190546atropine sulfate 1 MG in 10 ML Prefilled SyringePSN46ba6000-b842-449a-8dd4-7bb9dc7a74c56
119054610 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCD46ba6000-b842-449a-8dd4-7bb9dc7a74c56
1190546atropine sulfate 1 MG per 10 ML Prefilled SyringeSY46ba6000-b842-449a-8dd4-7bb9dc7a74c56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3120-07051831200010 CARTON in 1 PACKAGE (70518-3120-0) / 1 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGE10 carton2021-06-140000-00-00NoNoCurrent