FDA.reportPublic FDA data

Olopatadine Hydrochloride

Product NDC
68788-6317
11-digit product format
687886317
Labeler code
68788
Product ID
68788-6317_944a843d-99dc-4fbf-a63e-7731322d2db6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olopatadine Hydrochloride 0.1%
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA204706
Marketing category
ANDA
Marketing start
2017-03-27
Marketing end
0000-00-00
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-6317DDiscontinued by firm2026-07-31
excluded packagepackage68788-631768788-6317-5DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204706-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A204706-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07a50c72e98297…