Olopatadine hydrochloride

Product NDC
51407-663
11-digit product format
514070663
Labeler code
51407
Product ID
51407-663_445f4401-cd57-82ed-e063-6394a90a1a3f
Type
HUMAN OTC DRUG
Nonproprietary name
Olopatadine hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Golden State Medical Supply, Inc.
Application
ANDA078350
Marketing category
ANDA
Marketing start
2015-12-07
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Olopatadine hydrochloride
Listing expiration
2026-12-31

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
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
51407-663-05Olopatadine hydrochloride1 in 1 CARTONSOLUTION/ DROPS14
51407-663-05Olopatadine hydrochloride5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-663OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS [GOLDEN STATE MEDICAL SUPPLY, INC.]3Current NDC, Legacy NDC, 2 package rows20241212_ec0c8c56-68d2-e63e-e053-2995a90a8db2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSNec0c8c56-68d2-e63e-e053-2995a90a8db24
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCDec0c8c56-68d2-e63e-e053-2995a90a8db24
1111339olopatadine 0.1 % Ophthalmic SolutionSYec0c8c56-68d2-e63e-e053-2995a90a8db24
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSYec0c8c56-68d2-e63e-e053-2995a90a8db24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-663-05514070663051 BOTTLE, PLASTIC in 1 CARTON (51407-663-05) / 5 mL in 1 BOTTLE, PLASTIC2022-10-030000-00-00NoNoCurrent