ATROPINE SULFATE

Product NDC
51662-1527
11-digit product format
516621527
Labeler code
51662
Product ID
51662-1527_0f95174b-004a-2b38-e063-6394a90a0ac9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATROPINE SULFATE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA212461
Marketing category
ANDA
Marketing start
2021-04-25
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
51662-1527-1ATROPINE SULFATE1 in 1 CARTONINJECTION13
51662-1527-1ATROPINE SULFATE10 mL in 1 SYRINGEINJECTION103
51662-1527-2ATROPINE SULFATE1 in 1 POUCHINJECTION13
51662-1527-3ATROPINE SULFATE10 in 1 CASEINJECTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1527ATROPINE SULFATE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]3Current NDC, Legacy NDC, 4 package rows20240123_c0d0ca2a-4267-41b7-e053-2a95a90a4726.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190546atropine sulfate 1 MG in 10 ML Prefilled SyringePSNc0d0ca2a-4267-41b7-e053-2a95a90a47263
119054610 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCDc0d0ca2a-4267-41b7-e053-2a95a90a47263
1190546atropine sulfate 1 MG per 10 ML Prefilled SyringeSYc0d0ca2a-4267-41b7-e053-2a95a90a47263

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1527-1516621527011 SYRINGE in 1 CARTON (51662-1527-1) > 10 mL in 1 SYRINGE1 syringe2021-04-250000-00-00NoNoCurrent
51662-1527-2516621527021 in 1 POUCHHistorical
51662-1527-35166215270310 POUCH in 1 CASE (51662-1527-3) / 1 CARTON in 1 POUCH (51662-1527-2) / 1 SYRINGE in 1 CARTON (51662-1527-1) / 10 mL in 1 SYRINGE10 pouch2023-09-22NoNoCurrent