Atropine

Product NDC
13985-606
11-digit product format
139850606
Labeler code
13985
Product ID
13985-606_d2f70a87-b14f-48da-9a18-84f8cedbe6c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
MWI
Application
NDA206289
Marketing category
NDA
Marketing start
2015-03-23
Marketing end
0000-00-00
Substance
ATROPINE SULFATE
Active strength
10 mg/mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13985-606-05Atropine1 in 1 CARTONSOLUTION/ DROPS14
13985-606-05Atropine5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS54

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Atropine SulfateACTIVE INGREDIENT03J5ZE7KA5ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1
AtropineACTIVE MOIETY7C0697DR9IATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1
Hypromellose 2910 (4000 MPA.S)INACTIVE INGREDIENTRN3152OP35ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1
Sodium Phosphate, DibasicINACTIVE INGREDIENTGR686LBA74ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1
Sodium Phosphate, MonobasicINACTIVE INGREDIENT3980JIH2SWATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1
WaterINACTIVE INGREDIENT059QF0KO0RATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-606ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]4Legacy NDC, 2 package rows20220520_590a4e7b-565f-415f-a8e4-499a382c9a3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190655atropine sulfate 1 % Ophthalmic SolutionPSN590a4e7b-565f-415f-a8e4-499a382c9a3b4
1190655atropine sulfate 10 MG/ML Ophthalmic SolutionSCD590a4e7b-565f-415f-a8e4-499a382c9a3b4
1190655atropine sulfate 1 % Ophthalmic SolutionSY590a4e7b-565f-415f-a8e4-499a382c9a3b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13985-606-05139850606051 BOTTLE, DROPPER in 1 CARTON (13985-606-05) > 5 mL in 1 BOTTLE, DROPPER2015-03-230000-00-00NoNoCurrent