Atropine Sulfate

Product NDC
67296-2124
11-digit product format
672962124
Labeler code
67296
Product ID
67296-2124_4698b40d-9962-2dee-e063-6294a90a4287
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Redpharm Drug
Application
ANDA218148
Marketing category
ANDA
Marketing start
2024-01-08
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
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/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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
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
67296-2124-5Atropine Sulfate5 mL in 1 BOTTLESOLUTION/ DROPS54
67296-2124-5Atropine Sulfate1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-2124ATROPINE SULFATE SOLUTION/ DROPS [REDPHARM DRUG]1Current NDC, 2 package rows20250313_301ea0f4-a1dc-ad4f-e063-6294a90acc1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190655atropine sulfate 1 % Ophthalmic SolutionPSN301ea0f4-a1dc-ad4f-e063-6294a90acc1c4
1190655atropine sulfate 10 MG/ML Ophthalmic SolutionSCD301ea0f4-a1dc-ad4f-e063-6294a90acc1c4
1190655atropine sulfate 1 % Ophthalmic SolutionSY301ea0f4-a1dc-ad4f-e063-6294a90acc1c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2124-5672962124051 BOTTLE in 1 CARTON (67296-2124-5) / 5 mL in 1 BOTTLE1 bottle2024-01-08NoNoCurrent