FDA.reportPublic FDA data

Atropine Sulfate

Product NDC
72603-264
11-digit product format
726030264
Labeler code
72603
Product ID
72603-264_06c8d08d-9c13-4e79-a369-d5019b1795c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
NorthStar RxLLC
Application
ANDA218148
Marketing category
ANDA
Marketing start
2024-09-01
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
72603-264-01Atropine Sulfate1 in 1 CARTONSOLUTION/ DROPS13
72603-264-01Atropine Sulfate2 mL in 1 BOTTLESOLUTION/ DROPS23
72603-264-02Atropine Sulfate5 mL in 1 BOTTLESOLUTION/ DROPS53
72603-264-02Atropine Sulfate1 in 1 CARTONSOLUTION/ DROPS13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-264-01ML - Milliliter72603-264d73658af-3d83-4d99-8f3c-f9b7419ea93512024-11-05
72603-264-02ML - Milliliter72603-264ac44bc92-5cf6-4a68-89be-6423bdd1661612024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-264ATROPINE SULFATE SOLUTION/ DROPS [NORTHSTAR RXLLC]2Current NDC, 4 package rows20240901_f750135c-e6bf-4aa7-a343-87b1204df94f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190655atropine sulfate 1 % Ophthalmic SolutionPSNf750135c-e6bf-4aa7-a343-87b1204df94f3
1190655atropine sulfate 10 MG/ML Ophthalmic SolutionSCDf750135c-e6bf-4aa7-a343-87b1204df94f3
1190655atropine sulfate 1 % Ophthalmic SolutionSYf750135c-e6bf-4aa7-a343-87b1204df94f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-264-01726030264011 BOTTLE in 1 CARTON (72603-264-01) / 2 mL in 1 BOTTLE1 bottle2024-09-01NoNoHistorical
72603-264-02726030264021 BOTTLE in 1 CARTON (72603-264-02) / 5 mL in 1 BOTTLE1 bottle2024-09-01NoNoHistorical