FDA.reportPublic FDA data

Atropine Sulfate

Product NDC
70069-631
11-digit product format
700690631
Labeler code
70069
Product ID
70069-631_7a8a5552-fe21-4d36-8396-b7c99f41b4c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA215969
Marketing category
ANDA
Marketing start
2024-07-04
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
Rxcui1190795, 1666781

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
70069-631-01Atropine Sulfate1 mL in 1 VIALSOLUTION13
70069-631-25Atropine Sulfate25 in 1 CARTONSOLUTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-631-01ML - Milliliter70069-631837a2816-3f71-4223-8126-3130758099ee12024-08-12
70069-631-25ML - Milliliter70069-63148095b70-2583-425c-83a5-3572f4cd1c9f12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-631ATROPINE SULFATE SOLUTION [SOMERSET THERAPEUTICS, LLC]3Current NDC, 2 package rows20240705_a6fac578-c7bc-4b3c-a454-7889cc819118.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666781atropine sulfate 0.4 MG in 1 ML InjectionPSNa6fac578-c7bc-4b3c-a454-7889cc8191183
1190795atropine sulfate 1 MG in 1 ML InjectionPSNa6fac578-c7bc-4b3c-a454-7889cc8191183
16667811 ML atropine sulfate 0.4 MG/ML InjectionSCDa6fac578-c7bc-4b3c-a454-7889cc8191183
11907951 ML atropine sulfate 1 MG/ML InjectionSCDa6fac578-c7bc-4b3c-a454-7889cc8191183
1666781atropine sulfate 0.4 MG per 1 ML InjectionSYa6fac578-c7bc-4b3c-a454-7889cc8191183
1190795atropine sulfate 1 MG per 1 ML InjectionSYa6fac578-c7bc-4b3c-a454-7889cc8191183
1666781atropine sulfate 0.4 MG in 1 ML InjectionPSN3eef6300-9c78-82b2-e063-6294a90a54991
1666781atropine sulfate 0.4 MG in 1 ML InjectionPSN3fa81939-4495-28d5-e063-6394a90a1f2d1
16667811 ML atropine sulfate 0.4 MG/ML InjectionSCD3eef6300-9c78-82b2-e063-6294a90a54991
16667811 ML atropine sulfate 0.4 MG/ML InjectionSCD3fa81939-4495-28d5-e063-6394a90a1f2d1
1666781atropine sulfate 0.4 MG per 1 ML InjectionSY3eef6300-9c78-82b2-e063-6294a90a54991
1666781atropine sulfate 0.4 MG per 1 ML InjectionSY3fa81939-4495-28d5-e063-6394a90a1f2d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-631-01700690631011 mL in 1 VIAL1 mlHistorical
70069-631-257006906312525 VIAL in 1 CARTON (70069-631-25) / 1 mL in 1 VIAL (70069-631-01) 25 vial2024-07-04NoNoCurrent