FDA.reportPublic FDA data

Atropine Sulfate

Product NDC
82260-001
11-digit product format
822600001
Labeler code
82260
Product ID
82260-001_4a46793e-5e69-1a65-e063-6294a90a6880
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Bausch & Lomb Americas Inc.
Application
NDA213581
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2023-04-21
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
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 SULFATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii03J5ZE7KA5
Rxcui1190655

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
82260-001-01Atropine Sulfate10 in 1 CARTONSOLUTION104
82260-001-01Atropine Sulfate0.4 mL in 1 VIALSOLUTION0.44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82260-001-01EA - Each82260-001e8f50dfb-0f87-4b09-9a50-c9e73dc1653812023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82260-001ATROPINE SULFATE SOLUTION [BAUSCH & LOMB AMERICAS INC.]2Current NDC, 2 package rows20250416_e294ce2b-6bb5-4f84-8a6d-ce2402ed926d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190655atropine sulfate 1 % Ophthalmic SolutionPSNe294ce2b-6bb5-4f84-8a6d-ce2402ed926d4
1190655atropine sulfate 10 MG/ML Ophthalmic SolutionSCDe294ce2b-6bb5-4f84-8a6d-ce2402ed926d4
1190655atropine sulfate 1 % Ophthalmic SolutionSYe294ce2b-6bb5-4f84-8a6d-ce2402ed926d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82260-001-018226000010110 VIAL in 1 CARTON (82260-001-01) / .4 mL in 1 VIAL10 vial2023-04-21NoNoHistorical