Home NDC 58602-013 OLOPATADINE HYDROCHLORIDE
Product NDC 58602-013
11-digit product format 586020013
Labeler code 58602
Product ID 58602-013_223ca879-71fd-4a04-94d1-ae8aae206948
Type HUMAN OTC DRUG
Nonproprietary name OLOPATADINE HYDROCHLORIDE
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Aurohealth LLC
Application ANDA209995
Marketing category ANDA
Marketing start 2020-07-15
Substance OLOPATADINE HYDROCHLORIDE
Active strength 2 mg/mL
Pharmacologic classes Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209995-001 OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OPHTHALMIC 2019-04-04
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A209995-001 OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OPHTHALMIC 2019-04-04 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 16 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base OLOPATADINE HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLOPATADINE HYDROCHLORIDE 2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2XG66W44KF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1111343 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 58602-013-39 OLOPATADINE HYDROCHLORIDE 2.5 mL in 1 BOTTLE, PLASTIC SOLUTION 2.5 3 58602-013-39 OLOPATADINE HYDROCHLORIDE 1 in 1 CARTON SOLUTION 1 3 58602-013-41 OLOPATADINE HYDROCHLORIDE 2 in 1 CARTON SOLUTION 2 3 58602-013-41 OLOPATADINE HYDROCHLORIDE 2.5 mL in 1 BOTTLE, PLASTIC SOLUTION 2.5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58602-013 OLOPATADINE HYDROCHLORIDE SOLUTION [AUROHEALTH LLC] 3 Current NDC, Legacy NDC, 4 package rows 20201010_5f9e93e7-ff12-484d-add8-4f834193c1c6.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 58602-013-39 58602001339 1 BOTTLE, PLASTIC in 1 CARTON (58602-013-39) / 2.5 mL in 1 BOTTLE, PLASTIC 2020-07-15 0000-00-00 No No Current 58602-013-41 58602001341 2 BOTTLE, PLASTIC in 1 CARTON (58602-013-41) / 2.5 mL in 1 BOTTLE, PLASTIC 2020-07-15 0000-00-00 No No Current