FDA.reportPublic FDA data

Atropine Sulfate

Product NDC
70069-481
11-digit product format
700690481
Labeler code
70069
Product ID
70069-481_125328fe-c82b-42fd-bb3b-ba3f6c125ced
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate monohydrate
Dosage form
SOLUTION
Route
ENDOTRACHEAL; INTRAMEDULLARY; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA215005
Marketing category
ANDA
Marketing start
2024-12-09
Substance
ATROPINE SULFATE
Active strength
.4 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 SULFATE.4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii03J5ZE7KA5
Rxcui1190776

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-481-01Atropine Sulfate20 mL in 1 VIALSOLUTION203
70069-481-10Atropine Sulfate10 in 1 CARTONSOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-481-01ML - Milliliter70069-481bf0efd49-92c5-434e-977c-13d9d42c8a0512025-05-14
70069-481-10ML - Milliliter70069-481524d3945-0610-463d-950c-d31a923d0b5312025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-481ATROPINE SULFATE (ATROPINE SULFATE MONOHYDRATE) SOLUTION [SOMERSET THERAPEUTICS, LLC]3Current NDC, 2 package rows20241215_84ba1689-3030-48d5-9cce-70b5a24a4033.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190776atropine sulfate 0.4 MG/ML Injectable SolutionPSN84ba1689-3030-48d5-9cce-70b5a24a40333
1190776atropine sulfate 0.4 MG/ML Injectable SolutionSCD84ba1689-3030-48d5-9cce-70b5a24a40333
1190776atropine sulfate 1 MG per 2.5 ML Injectable SolutionSY84ba1689-3030-48d5-9cce-70b5a24a40333
1190776atropine sulfate 1.2 MG per 3 ML Injectable SolutionSY84ba1689-3030-48d5-9cce-70b5a24a40333
1190776atropine sulfate 2 MG per 5 ML Injectable SolutionSY84ba1689-3030-48d5-9cce-70b5a24a40333
1190776atropine sulfate 8 MG per 20 ML Injectable SolutionSY84ba1689-3030-48d5-9cce-70b5a24a40333
1190776atropine sulfate 0.4 MG/ML Injectable SolutionPSN423fc064-57cb-8308-e063-6394a90a26171
1190776atropine sulfate 0.4 MG/ML Injectable SolutionSCD423fc064-57cb-8308-e063-6394a90a26171
1190776atropine sulfate 1 MG per 2.5 ML Injectable SolutionSY423fc064-57cb-8308-e063-6394a90a26171
1190776atropine sulfate 1.2 MG per 3 ML Injectable SolutionSY423fc064-57cb-8308-e063-6394a90a26171
1190776atropine sulfate 2 MG per 5 ML Injectable SolutionSY423fc064-57cb-8308-e063-6394a90a26171
1190776atropine sulfate 8 MG per 20 ML Injectable SolutionSY423fc064-57cb-8308-e063-6394a90a26171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-481-017006904810120 mL in 1 VIAL20 mlHistorical
70069-481-107006904811010 VIAL in 1 CARTON (70069-481-10) / 20 mL in 1 VIAL (70069-481-01) 10 vial2024-12-09NoNoCurrent