FDA.reportPublic FDA data

OLOPATADINE HYDROCHLORIDE

Product NDC
46122-672
11-digit product format
461220672
Labeler code
46122
Product ID
46122-672_7420f7f2-f791-4d48-8f17-a9916bd8aa4b
Type
HUMAN OTC DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Amerisource Bergen
Application
ANDA204812
Marketing category
ANDA
Marketing start
2021-01-20
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
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
46122-672-64OLOPATADINE HYDROCHLORIDE1 in 1 CARTONSOLUTION14
46122-672-64OLOPATADINE HYDROCHLORIDE5 mL in 1 BOTTLE, PLASTICSOLUTION54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-672-64ML - Milliliter46122-672a770f76e-5b1b-48af-abf3-63e701c3a4eb12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-672OLOPATADINE HYDROCHLORIDE SOLUTION [AMERISOURCE BERGEN]4Current NDC, Legacy NDC, 2 package rows20230711_f3b054d2-4abd-4a1f-910d-0c61e2a24fbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSNf3b054d2-4abd-4a1f-910d-0c61e2a24fbf4
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCDf3b054d2-4abd-4a1f-910d-0c61e2a24fbf4
1111339olopatadine 0.1 % Ophthalmic SolutionSYf3b054d2-4abd-4a1f-910d-0c61e2a24fbf4
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSYf3b054d2-4abd-4a1f-910d-0c61e2a24fbf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-672-64461220672641 BOTTLE, PLASTIC in 1 CARTON (46122-672-64) / 5 mL in 1 BOTTLE, PLASTIC2021-01-200000-00-00NoNoCurrent