FDA.reportPublic FDA data

Olopatadine Hydrochloride Ophthalmic Solution

Product NDC
68083-231
11-digit product format
680830231
Labeler code
68083
Product ID
68083-231_4657bfb5-f22c-4739-9455-f3ca695d0e5d
Type
HUMAN OTC DRUG
Nonproprietary name
Olopatadine Hydrochloride Ophthalmic
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Gland Pharma Limited
Application
ANDA209752
Marketing category
ANDA
Marketing start
2020-05-20
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

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 HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2XG66W44KF
Rxcui1111343

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
abab02bf-82c6-4b6c-8cb4-2ee39055aeb1Product name320210312
ee1438f7-d464-b7de-1b3a-aae378f7d672Product name820200121
4101b788-a943-3f81-6947-4acf7be2af4dProduct name420190703
ca2d4a1a-2b5b-4256-9aad-735e9282b3eeProduct name120150323
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-231-01Olopatadine Hydrochloride Ophthalmic Solution2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.52
68083-231-01Olopatadine Hydrochloride Ophthalmic Solution1 in 1 CARTONSOLUTION12
68083-231-85Olopatadine Hydrochloride Ophthalmic Solution2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.52
68083-231-85Olopatadine Hydrochloride Ophthalmic Solution1000 in 1 CASESOLUTION10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-231OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION [GLAND PHARMA LIMITED]2Current NDC, Legacy NDC, 2 package rows20221111_70233f0d-c170-4a1b-8c07-417e2c1e4e86.zip
68083-231OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION [GLAND PHARMA LIMITED]1Current NDC, Legacy NDC, 2 package rows20200525_9a4c58dc-aee6-441f-8081-608e4fd36193.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSNf249d79e-0f62-d2f1-bcbc-22dda253aad24
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCDf249d79e-0f62-d2f1-bcbc-22dda253aad24
1111343olopatadine 0.2 % Ophthalmic SolutionSYf249d79e-0f62-d2f1-bcbc-22dda253aad24
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSYf249d79e-0f62-d2f1-bcbc-22dda253aad24
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSN9a4c58dc-aee6-441f-8081-608e4fd361932
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCD9a4c58dc-aee6-441f-8081-608e4fd361932
1111343olopatadine 0.2 % Ophthalmic SolutionSY9a4c58dc-aee6-441f-8081-608e4fd361932
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSY9a4c58dc-aee6-441f-8081-608e4fd361932

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-231-01680830231011 BOTTLE, PLASTIC in 1 CARTON (68083-231-01) / 2.5 mL in 1 BOTTLE, PLASTIC2020-05-200000-00-00NoNoCurrent
68083-231-85680830231852.5 mL in 1 BOTTLE, PLASTIC2.5 mlHistorical