FDA.reportPublic FDA data

Olopatadine Hydrochloride Ophthalmic Solution

Product NDC
0536-1308
11-digit product format
005361308
Labeler code
0536
Product ID
0536-1308_9d39e5da-cb1e-a420-e72b-c6d297bd880f
Type
HUMAN OTC DRUG
Nonproprietary name
Olopatadine Hydrochloride Ophthalmic
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Rugby Laboratories
Application
ANDA209619
Marketing category
ANDA
Marketing start
2021-01-05
Marketing end
2026-06-30
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
1 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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Olopatadine Hydrochloride Ophthalmic Solution

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLOPATADINE HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2XG66W44KF
Rxcui1111339

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1308-40Olopatadine Hydrochloride Ophthalmic Solution1 in 1 CARTONSOLUTION/ DROPS16
0536-1308-40Olopatadine Hydrochloride Ophthalmic Solution5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1308-40ML - Milliliter0536-13088c84710f-1a68-4670-a3a2-7f6dcc353cab12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1308OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION/ DROPS [RUGBY LABORATORIES ]3Current NDC, Legacy NDC, 2 package rows20230629_d7bcba63-bfaf-240b-199e-2e42a91c19c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSNd7bcba63-bfaf-240b-199e-2e42a91c19c96
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCDd7bcba63-bfaf-240b-199e-2e42a91c19c96
1111339olopatadine 0.1 % Ophthalmic SolutionSYd7bcba63-bfaf-240b-199e-2e42a91c19c96
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSYd7bcba63-bfaf-240b-199e-2e42a91c19c96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0536-1308-40005361308401 BOTTLE, PLASTIC in 1 CARTON (0536-1308-40) / 5 mL in 1 BOTTLE, PLASTIC2021-01-052026-06-30NoNoCurrent