Home NDC 70069-491 OLOPATADINE HYDROCHLORIDE
Product NDC 70069-491
11-digit product format 700690491
Labeler code 70069
Product ID 70069-491_78c4829c-7c27-4a0a-a92f-c0596f773a74
Type HUMAN OTC DRUG
Nonproprietary name Olopatadine Hydrochloride
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Somerset Therapeutics, LLC
Application ANDA215006
Marketing category ANDA
Marketing start 2024-12-20
Substance OLOPATADINE HYDROCHLORIDE
Active strength 2 mg/mL
Pharmacologic classes Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A215006-001 OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OPHTHALMIC 2024-12-18
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 2026-09-14 22:38:34 2026-08 A215006-001 OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OPHTHALMIC 2024-12-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215006-001 OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OPHTHALMIC 2024-12-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215006-001 OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OPHTHALMIC 2024-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215006-001 OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OPHTHALMIC 2024-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215006-001 OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OPHTHALMIC 2024-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215006-001 OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OPHTHALMIC 2024-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215006-001 OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OPHTHALMIC 2024-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215006-001 OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OPHTHALMIC 2024-12-18 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215006-001 OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS / OPHTHALMIC 2024-12-18 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base OLOPATADINE HYDROCHLORIDE
Listing expiration 2027-12-31 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 70069-491-01 OLOPATADINE HYDROCHLORIDE 2.5 mL in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 2.5 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70069-491 OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC] 7 Current NDC, 1 package rows 20241222_6ee9f8f5-973c-4c71-8069-e76cd87b07dc.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 Marketing start Sample Exclude flag Status 70069-491-01 70069049101 1 BOTTLE, PLASTIC in 1 CARTON (70069-491-01) / 2.5 mL in 1 BOTTLE, PLASTIC 2024-12-20 No No Current