FDA.reportPublic FDA data

Atropine

Product NDC
17478-215
11-digit product format
174780215
Labeler code
17478
Product ID
17478-215_51435c38-594f-40d4-8823-54571228665b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
NDA206289
Marketing category
NDA
Marketing start
2014-07-18
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17478-215-022024-01-30C16284748780-11030e365-06ff-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE ophthalmic solution, for topical application to the eye. Initial U.S. Approval: 1960
17478-215-052024-01-30C16284748780-11030e365-06ff-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE ophthalmic solution, for topical application to the eye. Initial U.S. Approval: 1960
17478-215-152024-01-30C16284748780-11030e365-06ff-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE ophthalmic solution, for topical application to the eye. Initial U.S. Approval: 1960

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-215-02Atropine1 in 1 CARTONSOLUTION/ DROPS112
17478-215-02Atropine2 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS212
17478-215-05Atropine1 in 1 CARTONSOLUTION/ DROPS112
17478-215-05Atropine5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS512
17478-215-15Atropine15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1512
17478-215-15Atropine1 in 1 CARTONSOLUTION/ DROPS112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-215-02ML - Milliliter17478-215d208eb02-efba-4172-ab10-3cef63f4bea612015-01-05
17478-215-05ML - Milliliter17478-215435428bf-523c-4903-a211-8f95f24287cf12015-01-05
17478-215-15ML - Milliliter17478-215be37c0b8-846c-4e76-922e-1658bb03799f12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Atropine SulfateACTIVE INGREDIENT03J5ZE7KA5ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [AKORN, INC.]7
AtropineACTIVE MOIETY7C0697DR9IATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [AKORN, INC.]7
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [AKORN, INC.]7
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [AKORN, INC.]7
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [AKORN, INC.]7
Hypromellose 2910 (4000 MPA.S)INACTIVE INGREDIENTRN3152OP35ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [AKORN, INC.]7
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [AKORN, INC.]7
Sodium Phosphate, DibasicINACTIVE INGREDIENTGR686LBA74ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [AKORN, INC.]7
Sodium Phosphate, MonobasicINACTIVE INGREDIENT3980JIH2SWATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [AKORN, INC.]7
WaterINACTIVE INGREDIENT059QF0KO0RATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [AKORN, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-215ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [AKORN]12Legacy NDC, 6 package rows20220702_f7b40bf1-3063-4849-a5a0-0ac5d0d1e72a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190655atropine sulfate 1 % Ophthalmic SolutionPSNf7b40bf1-3063-4849-a5a0-0ac5d0d1e72a12
1190655atropine sulfate 10 MG/ML Ophthalmic SolutionSCDf7b40bf1-3063-4849-a5a0-0ac5d0d1e72a12
1190655atropine sulfate 1 % Ophthalmic SolutionSYf7b40bf1-3063-4849-a5a0-0ac5d0d1e72a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-215-02174780215021 BOTTLE, DROPPER in 1 CARTON (17478-215-02) > 2 mL in 1 BOTTLE, DROPPER2014-07-180000-00-00NoNoCurrent
17478-215-05174780215051 BOTTLE, DROPPER in 1 CARTON (17478-215-05) > 5 mL in 1 BOTTLE, DROPPER2014-07-180000-00-00NoNoCurrent
17478-215-15174780215151 BOTTLE, DROPPER in 1 CARTON (17478-215-15) > 15 mL in 1 BOTTLE, DROPPER2014-07-180000-00-00NoNoCurrent