FDA.reportPublic FDA data

Atropine Sulfate

Product NDC
64253-400
11-digit product format
642530400
Labeler code
64253
Product ID
64253-400_46a6a31f-46ab-a437-e063-6394a90a4ad0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate Injection
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Medefil, Inc.
Application
ANDA214970
Marketing category
ANDA
Marketing start
2023-05-11
Substance
ATROPINE SULFATE
Active strength
.1 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.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii03J5ZE7KA5
Rxcui1190546

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
64253-400-30Atropine Sulfate10 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION102
64253-400-91Atropine Sulfate10 in 1 BOXINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64253-400-30ML - Milliliter64253-400f259a78b-6db7-4041-9531-955d5fee45cc12023-08-08
64253-400-91ML - Milliliter64253-400b1b8fd6a-b329-466d-a231-c68ab4c6c70f12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64253-400ATROPINE SULFATE (ATROPINE SULFATE INJECTION) INJECTION, SOLUTION [MEDEFIL, INC.]1Current NDC, 2 package rows20230528_fbfdf718-befe-ad22-e053-6294a90a3715.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190546atropine sulfate 1 MG in 10 ML Prefilled SyringePSNfbfdf718-befe-ad22-e053-6294a90a37152
119054610 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCDfbfdf718-befe-ad22-e053-6294a90a37152
1190546atropine sulfate 1 MG per 10 ML Prefilled SyringeSYfbfdf718-befe-ad22-e053-6294a90a37152
1190546atropine sulfate 1 MG in 10 ML Prefilled SyringePSN3eeed115-0e17-c4b2-e063-6294a90a29b71
119054610 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCD3eeed115-0e17-c4b2-e063-6294a90a29b71
1190546atropine sulfate 1 MG per 10 ML Prefilled SyringeSY3eeed115-0e17-c4b2-e063-6294a90a29b71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64253-400-306425304003010 mL in 1 SYRINGE, PLASTIC10 mlHistorical
64253-400-916425304009110 SYRINGE, PLASTIC in 1 BOX (64253-400-91) / 10 mL in 1 SYRINGE, PLASTIC (64253-400-30) 2023-05-11NoNoHistorical