FDA.reportPublic FDA data

ATROPINE SULFATE

Product NDC
51662-1339
11-digit product format
516621339
Labeler code
51662
Product ID
51662-1339_ef6d3da2-6bf8-fbc7-e053-2a95a90a74cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATROPINE SULFATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-12-21
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51662-1339IInactivated by FDA2026-10-05
excluded packagepackage51662-133951662-1339-1IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51662-1339-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51662-1339-1f5e01cc5f278…a2eaf40c39c3…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51662-1339-12020-02-07C16284748780-19d75b9d0-14bc-f424-e053-dadaa90a57ceATROPINE SULFATE INJECTION, USP 0.4mg/mL 1mL VIAL
51662-1339-12020-01-31C16284748780-19d75b9d0-14bc-f424-e053-dadaa90a57ceATROPINE SULFATE INJECTION, USP 0.4mg/mL 1mL VIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1339-1ATROPINE SULFATE1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1339ATROPINE SULFATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]4Legacy NDC, 1 package rows20221211_7d8fc6fd-1eb5-30b6-e053-2a91aa0aa9f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666781atropine sulfate 0.4 MG in 1 ML InjectionPSN7d8fc6fd-1eb5-30b6-e053-2a91aa0aa9f04
16667811 ML atropine sulfate 0.4 MG/ML InjectionSCD7d8fc6fd-1eb5-30b6-e053-2a91aa0aa9f04
1666781atropine sulfate 0.4 MG per 1 ML InjectionSY7d8fc6fd-1eb5-30b6-e053-2a91aa0aa9f04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1339-1516621339011 mL in 1 VIAL, SINGLE-DOSE (51662-1339-1) 1 ml2018-12-210000-00-00NoNoCurrent