FDA.reportPublic FDA data

Atropine Sulfate

Product NDC
24208-825
11-digit product format
242080825
Labeler code
24208
Product ID
24208-825_72b36d2b-77a4-4b9e-b99d-99bf20e45cc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1990-09-30
Substance
ATROPINE SULFATE
Active strength
10 mg/g
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 SULFATE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii03J5ZE7KA5
Rxcui1190570

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
24208-825-55Atropine Sulfate1 in 1 CARTONOINTMENT18
24208-825-55Atropine Sulfate3.5 g in 1 TUBEOINTMENT3.58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-825-55GM - Gram24208-825e15946a9-0511-4ff9-b916-4756e1f0d25612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5ATROPINE SULFATE OINTMENT [BAUSCH & LOMB INCORPORATED]3
ATROPINEACTIVE MOIETY7C0697DR9IATROPINE SULFATE OINTMENT [BAUSCH & LOMB INCORPORATED]3
LANOLIN OILINACTIVE INGREDIENTOVV5IIJ58FATROPINE SULFATE OINTMENT [BAUSCH & LOMB INCORPORATED]3
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPATROPINE SULFATE OINTMENT [BAUSCH & LOMB INCORPORATED]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UATROPINE SULFATE OINTMENT [BAUSCH & LOMB INCORPORATED]3
WATERINACTIVE INGREDIENT059QF0KO0RATROPINE SULFATE OINTMENT [BAUSCH & LOMB INCORPORATED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-825ATROPINE SULFATE OINTMENT [BAUSCH & LOMB INCORPORATED]8Current NDC, Legacy NDC, 2 package rows20231230_c0a56d60-0914-42b1-af59-c56afe93d18c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190570atropine sulfate 1 % Ophthalmic OintmentPSNc0a56d60-0914-42b1-af59-c56afe93d18c8
1190570atropine sulfate 0.01 MG/MG Ophthalmic OintmentSCDc0a56d60-0914-42b1-af59-c56afe93d18c8
1190570atropine sulfate 1 % Ophthalmic OintmentSYc0a56d60-0914-42b1-af59-c56afe93d18c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24208-825-55242080825551 TUBE in 1 CARTON (24208-825-55) / 3.5 g in 1 TUBE1 tube1990-09-300000-00-00NoNoCurrent