Home NDC 51316-567-01 Olopatadine Hydrochloride Ophthalmic Solution
Product NDC 51316-567
Requested package NDC 51316-567-01
11-digit product format 513160567
Labeler code 51316
Product ID 51316-567_3fe3c75e-cb1f-bb27-8b6e-6f34dee09a0e
Type HUMAN OTC DRUG
Nonproprietary name olopatadine hydrochloride ophthalmic
Dosage form SOLUTION
Route OPHTHALMIC
Labeler CVS Pharmacy
Application ANDA213514
Marketing category ANDA
Marketing start 2026-01-15
Substance OLOPATADINE HYDROCHLORIDE
Active strength 7 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 2026-12-31
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 A213514-001 OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.7% BASE SOLUTION/DROPS / OPHTHALMIC 2026-01-06
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 A213514-001 OLOPATADINE HYDROCHLORIDE EQ 0.7% BASE SOLUTION/DROPS / OPHTHALMIC 2026-01-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213514-001 OLOPATADINE HYDROCHLORIDE EQ 0.7% BASE SOLUTION/DROPS / OPHTHALMIC 2026-01-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213514-001 OLOPATADINE HYDROCHLORIDE EQ 0.7% BASE SOLUTION/DROPS / OPHTHALMIC 2026-01-06 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213514-001 OLOPATADINE HYDROCHLORIDE EQ 0.7% BASE SOLUTION/DROPS / OPHTHALMIC 2026-01-06 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 Ophthalmic Solution
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLOPATADINE HYDROCHLORIDE 7 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 1601086 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 51316-567-01 Olopatadine Hydrochloride Ophthalmic Solution 2.5 mL in 1 BOTTLE SOLUTION 2.5 1 51316-567-01 Olopatadine Hydrochloride Ophthalmic Solution 1 in 1 CARTON SOLUTION 1 1
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 · 9 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51316-567-01 51316056701 1 BOTTLE in 1 CARTON (51316-567-01) / 2.5 mL in 1 BOTTLE 1 bottle 2026-01-15 No No Current