Home NDC 59390-192 HOMATROPINE HYDROBROMIDE OPHTHALMIC
Product NDC 59390-192
11-digit product format 593900192
Labeler code 59390
Product ID 59390-192_5190a5bc-5820-4874-bbe7-32576266a72f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Homatropine Hydrobromide
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Altaire Pharmaceuticals Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2018-06-01
Substance HOMATROPINE HYDROBROMIDE
Active strength 50 mg/mL
Pharmacologic classes 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 HOMATROPINE HYDROBROMIDE OPHTHALMIC
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMATROPINE HYDROBROMIDE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BEW7469QZ0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 992757 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59390-192-05 HOMATROPINE HYDROBROMIDE OPHTHALMIC 5 mL in 1 BOTTLE, PLASTIC SOLUTION 5 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59390-192 HOMATROPINE HYDROBROMIDE OPHTHALMIC (HOMATROPINE HYDROBROMIDE) SOLUTION [ALTAIRE PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 1 package rows 20221101_f3ffd601-182f-4f04-b1cc-8175bc2e32fe.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59390-192-05 59390019205 5 mL in 1 BOTTLE, PLASTIC (59390-192-05) 5 ml 2018-06-01 0000-00-00 No No Current