FDA.reportPublic FDA data

olopatadine hydrochloride ophthalmic solution

Manufacturer
Gland Pharma Limited
Effective date
2026-01-28
Label type
Bulk Ingredient
Version
1
Source
full-release
Hydrated at
2026-06-01 02:52:25

Label at a glance#

Productolopatadine hydrochloride ophthalmic solution
Active ingredientOLOPATADINE HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BULK LABEL

NDC 68083-398-85

Olopatadine Hydrochloride Ophthalmic Solution, USP, 0.7%.

Quantity- 1,000 - 2.5 mL fill Bottles

Batch No. : AXXXXXXX

Exp. Date : MM/YYYY

Store at 2°-25°C (36°-77°F)

CAUTION: For Manufacturing, processing or repackaging only.

Manufactured by :

Gland Pharma Limited

D.P. Pally, Hyderabad - 500043, INDIA

Code: AP/DRUGS/103/97

olopatadine-bulkolopatadine-bulk

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OLOPATADINE Pharmacologic Class Indexing4Indexing - Pharmacologic Class20220128

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130368083398859GTIN-13: 0368083398859
EAN-13: 0368083398859
GTIN-12: 368083398859
UPC-A: 368083398859
GTIN storage (14 digits): 00368083398859		olopatadine-bulk.jpg
BarcodeEAN-130368083798819GTIN-13: 0368083798819
EAN-13: 0368083798819
GTIN-12: 368083798819
UPC-A: 368083798819
GTIN storage (14 digits): 00368083798819		olopatadine-bulk.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
abab02bf-82c6-4b6c-8cb4-2ee39055aeb1Product name320210312
ee1438f7-d464-b7de-1b3a-aae378f7d672Product name820200121
4101b788-a943-3f81-6947-4acf7be2af4dProduct name420190703
ca2d4a1a-2b5b-4256-9aad-735e9282b3eeProduct name120150323
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-398-85olopatadine hydrochloride ophthalmic solution1000 in 1 CASESOLUTION10001
68083-398-85olopatadine hydrochloride ophthalmic solution2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.51

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68083-39868083-398-85

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLOPATADINE HYDROCHLORIDE2XG66W44KFACTIM
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
HYDROCHLORIC ACIDQTT17582CBIACT
HYDROXYPROPYL .GAMMA.-CYCLODEXTRINP6BYU725IUIACT
HYPROMELLOSE 2910 (4000 MPA.S)RN3152OP35IACT
MANNITOL3OWL53L36AIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONE K30U725QWY32XIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A213514-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.7% BASESOLUTION/DROPS / OPHTHALMIC2026-01-06

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A213514-001OLOPATADINE HYDROCHLORIDEEQ 0.7% BASESOLUTION/DROPS / OPHTHALMIC2026-01-06c2088c7a36db…
2026-09-14 22:38:342026-08A213514-001OLOPATADINE HYDROCHLORIDEEQ 0.7% BASESOLUTION/DROPS / OPHTHALMIC2026-01-0684e616aacf4f…
2026-08-18 06:07:402026-07A213514-001OLOPATADINE HYDROCHLORIDEEQ 0.7% BASESOLUTION/DROPS / OPHTHALMIC2026-01-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213514-001OLOPATADINE HYDROCHLORIDEEQ 0.7% BASESOLUTION/DROPS / OPHTHALMIC2026-01-06011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213514-001OLOPATADINE HYDROCHLORIDEEQ 0.7% BASESOLUTION/DROPS / OPHTHALMIC2026-01-06a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICGland Pharma Limiteda3475f8c-c780-43c0-b22f-08a0ce5608fd2026-01-07WarningsExact identifier
ndc (product): 68083-398

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.