Eye Allergy Itch and Redness Relief

Product NDC
70000-0054
11-digit product format
700000054
Labeler code
70000
Product ID
70000-0054_5104f5a9-ebf6-c7a1-6eb2-f43a025f699f
Type
HUMAN OTC DRUG
Nonproprietary name
Olopatadine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER
Application
ANDA209619
Marketing category
ANDA
Marketing start
2021-01-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Eye Allergy Itch and Redness Relief
Listing expiration
2027-12-31

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
70000-0054-1Eye Allergy Itch and Redness Relief5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS58
70000-0054-1Eye Allergy Itch and Redness Relief1 in 1 CARTONSOLUTION/ DROPS18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0054-1ML - Milliliter70000-0054dc8eb58f-3104-43fb-b8ab-c07302e13c1e12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0054EYE ALLERGY ITCH AND REDNESS RELIEF (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION/ DROPS [LEADER/ CARDINAL HEALTH 110, INC.]4Current NDC, Legacy NDC, 2 package rows20231015_5255d142-7d04-ab80-fa97-b11c4486e42c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSN5255d142-7d04-ab80-fa97-b11c4486e42c8
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCD5255d142-7d04-ab80-fa97-b11c4486e42c8
1111339olopatadine 0.1 % Ophthalmic SolutionSY5255d142-7d04-ab80-fa97-b11c4486e42c8
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSY5255d142-7d04-ab80-fa97-b11c4486e42c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0054-1700000054011 BOTTLE, DROPPER in 1 CARTON (70000-0054-1) / 5 mL in 1 BOTTLE, DROPPER2021-01-150000-00-00NoNoCurrent