Atropine

Product NDC
50090-7000
11-digit product format
500907000
Labeler code
50090
Product ID
50090-7000_e572b532-c04e-470b-94d3-ec04b32835e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA215624
Marketing category
ANDA
Marketing start
2021-11-26
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
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
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
50090-7000-0Atropine5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS51
50090-7000-0Atropine1 in 1 CARTONSOLUTION/ DROPS11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7000-0ML - Milliliter50090-7000859d3969-93f8-4f2f-beb6-03cca3cb85a912024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7000ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20240103_1b2d030e-c0ec-484b-a228-76011702cdd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190655atropine sulfate 1 % Ophthalmic SolutionPSN1b2d030e-c0ec-484b-a228-76011702cdd01
1190655atropine sulfate 10 MG/ML Ophthalmic SolutionSCD1b2d030e-c0ec-484b-a228-76011702cdd01
1190655atropine sulfate 1 % Ophthalmic SolutionSY1b2d030e-c0ec-484b-a228-76011702cdd01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7000-0500907000001 BOTTLE, DROPPER in 1 CARTON (50090-7000-0) / 5 mL in 1 BOTTLE, DROPPER2023-12-28NoNoCurrent