FDA.reportPublic FDA data

Atropine Sulfate

Product NDC
52584-910
Requested package NDC
52584-910-34
11-digit product format
525840910
Labeler code
52584
Product ID
52584-910_d6ede41b-aa62-46d5-854b-567765f80222
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
General Injectables & Vaccines, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2010-03-01
Marketing end
2024-01-01
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
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52584-91052584-910-34DDiscontinued by firm2026-10-12

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Atropine SulfateACTIVE INGREDIENT03J5ZE7KA5ATROPINE SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.]3
AtropineACTIVE MOIETY7C0697DR9IATROPINE SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.]3
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XATROPINE SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52584-910-34525840910341 SYRINGE in 1 BAG (52584-910-34) > 5 mL in 1 SYRINGE1 syringe2018-07-092024-01-01NoNoCurrent