FDA.reportPublic FDA data

Atropine sulfate

Product NDC
70069-582
11-digit product format
700690582
Labeler code
70069
Product ID
70069-582_43d3dd59-36b1-493f-86a3-c5eee9750ee8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Somerset Therapeutics, LLC
Application
ANDA215618
Marketing category
ANDA
Marketing start
2024-07-04
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
70069-582-01Atropine sulfate1 in 1 CARTONSOLUTION/ DROPS18
70069-582-01Atropine sulfate5 mL in 1 BOTTLESOLUTION/ DROPS58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-582-01ML - Milliliter70069-5825ab026c4-560e-4a77-943d-27574cc9ba5f12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-582ATROPINE SULFATE SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC]7Current NDC, 2 package rows20240705_e30491ed-938e-4ef4-aa23-a2e94cbab0ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190655atropine sulfate 1 % Ophthalmic SolutionPSNe30491ed-938e-4ef4-aa23-a2e94cbab0ed8
1190655atropine sulfate 10 MG/ML Ophthalmic SolutionSCDe30491ed-938e-4ef4-aa23-a2e94cbab0ed8
1190655atropine sulfate 1 % Ophthalmic SolutionSYe30491ed-938e-4ef4-aa23-a2e94cbab0ed8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-582-01700690582011 BOTTLE in 1 CARTON (70069-582-01) / 5 mL in 1 BOTTLE1 bottle2024-07-04NoNoCurrent