FDA.reportPublic FDA data

Olopatadine Hydrochloride Ophthalmic Solution

Product NDC
68083-398
Requested package NDC
68083-398-01
11-digit product format
680830398
Labeler code
68083
Product ID
68083-398_e05ea1df-8db8-4261-be59-8f303da3b57e
Type
HUMAN OTC DRUG
Nonproprietary name
olopatadine hydrochloride ophthalmic
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Gland Pharma Limited
Application
ANDA213514
Marketing category
ANDA
Marketing start
2026-01-06
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
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-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
2026-09-14 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…

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLOPATADINE HYDROCHLORIDE7 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2XG66W44KFInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1601086Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a3475f8c-c780-43c0-b22f-08a0ce5608fdAvailable on FDA.report

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
68083-398-01Olopatadine Hydrochloride Ophthalmic Solution2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.52
68083-398-01Olopatadine Hydrochloride Ophthalmic Solution1 in 1 CARTONSOLUTION12
68083-398-85olopatadine hydrochloride ophthalmic solution1000 in 1 CASESOLUTION10001
68083-398-85olopatadine hydrochloride ophthalmic solution2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.51

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.5295f8a2-4e0d-4b6e-9807-e2f36b1d5d152026-04-15WarningsExact identifier
application applno (ANDA): 213514
application number: ANDA213514
Eye Allergy Itch ReliefOLOPATADINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADER5d79fc06-a25f-debb-f08b-523ff26df9002026-02-24WarningsExact identifier
application applno (ANDA): 213514
application number: ANDA213514
Eye Allergy Itch ReliefOLOPATADINE HYDROCHLORIDETARGET CORPORATIONaa112cbd-35c0-a723-48cc-21137332b2c32026-02-03WarningsExact identifier
application applno (ANDA): 213514
application number: ANDA213514
Olopatadine HClOLOPATADINE HYDROCHLORIDERugby Laboratoriesedb068e2-1835-483e-e59c-bcbe13b66d762026-01-22WarningsExact identifier
application applno (ANDA): 213514
application number: ANDA213514
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICCVS Pharmacy56d56cb8-b04c-5f48-b0c3-5639a79fd2c52026-01-15WarningsExact identifier
application applno (ANDA): 213514
application number: ANDA213514
Eye Allergy Itch ReliefOLOPATADINE HYDROCHLORIDE OPHTHALMICDr. Reddy's Laboratories Inc.dab50913-940c-bcd5-725a-24c18a9f3ea62026-01-15WarningsExact identifier
application applno (ANDA): 213514
application number: ANDA213514
Eye Allergy Itch ReliefOLOPATADINE HYDROCHLORIDE OPHTHALMICWalgreen Company56a99d87-b88b-d140-2dc7-08af5a9f45fb2026-01-15WarningsExact identifier
application applno (ANDA): 213514
application number: ANDA213514
Allergy Relief Eye DropsOLOPATADINE HYDROCHLORIDE OPHTHALMICCVS Pharmacydad4b9f2-f4f8-fe9a-ae9d-35511864dad02026-01-15WarningsExact identifier
application applno (ANDA): 213514
application number: ANDA213514
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICGland Pharma Limiteda3475f8c-c780-43c0-b22f-08a0ce5608fd2026-01-07WarningsExact identifier
application applno (ANDA): 213514
application number: ANDA213514
ndc (package): 68083-398-01
ndc (product): 68083-398
ndc11 (package): 68083039801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1601086olopatadine HCl 0.7 % Ophthalmic SolutionPSNa3475f8c-c780-43c0-b22f-08a0ce5608fd2
1601086olopatadine 7 MG/ML Ophthalmic SolutionSCDa3475f8c-c780-43c0-b22f-08a0ce5608fd2
1601086olopatadine 0.7 % Ophthalmic SolutionSYa3475f8c-c780-43c0-b22f-08a0ce5608fd2
1601086olopatadine 7 MG/ML (as olopatadine HCl 7.76 MG/ML) Ophthalmic SolutionSYa3475f8c-c780-43c0-b22f-08a0ce5608fd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68083-398-01680830398011 BOTTLE, PLASTIC in 1 CARTON (68083-398-01) / 2.5 mL in 1 BOTTLE, PLASTIC2026-01-06NoNoCurrent