Atropine

Product NDC
50090-7000
11-digit product format
500907000
Labeler code
50090
Product ID
50090-7000_e572b532-c04e-470b-94d3-ec04b32835e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA215624
Marketing category
ANDA
Marketing start
2021-11-26
Substance
ATROPINE SULFATE
Active strength
10 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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
03J5ZE7KA5ATROPINE SULFATE5908-99-6ATROPINE SULFATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7000-0500907000001 BOTTLE, DROPPER in 1 CARTON (50090-7000-0) / 5 mL in 1 BOTTLE, DROPPER2023-12-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AtropineA-S Medication Solutions2024-01-02HUMAN PRESCRIPTION DRUG LABEL1