FDA.reportPublic FDA data

ATROPINE SULFATE

Product NDC
51662-1207
11-digit product format
516621207
Labeler code
51662
Product ID
51662-1207_ed26eb52-8a4a-17c2-e053-2a95a90ab7d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATROPINE SULFATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co. LLC, DBA Health First
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-08-22
Marketing end
0000-00-00
Substance
ATROPINE SULFATE
Active strength
0 mg/mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51662-1207DDiscontinued by firm2026-11-10
excluded packagepackage51662-120751662-1207-1DDiscontinued by firm2026-11-10
excluded packagepackage51662-120751662-1207-3DDiscontinued by firm2026-11-10

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
51662-1207-1ATROPINE SULFATE1 in 1 CARTONINJECTION, SOLUTION110
51662-1207-1ATROPINE SULFATE10 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION1010
51662-1207-2ATROPINE SULFATE1 in 1 POUCHINJECTION, SOLUTION110
51662-1207-2ATROPINE SULFATE1 in 1 CARTONINJECTION, SOLUTION110
51662-1207-3ATROPINE SULFATE10 in 1 CASEINJECTION, SOLUTION1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1207ATROPINE SULFATE INJECTION, SOLUTION [HF ACQUISITION CO. LLC, DBA HEALTH FIRST]10Legacy NDC, 5 package rows20240310_74106ef7-83bf-47ba-e053-2991aa0aaec1.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co. LLC, DBA Health First74106ef7-83bf-47ba-e053-2991aa0aaec12024-03-08Warnings, Adverse reactionsExact identifier
ndc (product): 51662-1207

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190546atropine sulfate 1 MG in 10 ML Prefilled SyringePSN74106ef7-83bf-47ba-e053-2991aa0aaec110
119054610 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCD74106ef7-83bf-47ba-e053-2991aa0aaec110
1190546atropine sulfate 1 MG per 10 ML Prefilled SyringeSY74106ef7-83bf-47ba-e053-2991aa0aaec110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1207-1516621207011 SYRINGE, GLASS in 1 CARTON (51662-1207-1) > 10 mL in 1 SYRINGE, GLASS2018-08-220000-00-00NoNoCurrent
51662-1207-2516621207021 in 1 POUCHHistorical
51662-1207-35166212070310 POUCH in 1 CASE (51662-1207-3) > 1 CARTON in 1 POUCH (51662-1207-2) > 1 SYRINGE, GLASS in 1 CARTON > 10 mL in 1 SYRINGE, GLASS10 pouch2018-08-220000-00-00NoNoCurrent