FDA.reportPublic FDA data

OLOPATADINE HYDROCHLORIDE

Product NDC
79903-001
11-digit product format
799030001
Labeler code
79903
Product ID
79903-001_0c3d13c1-95fd-4bf6-ac9d-cf0b801b8568
Type
HUMAN OTC DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Wal-Mart Stores, Inc.
Application
ANDA209995
Marketing category
ANDA
Marketing start
2020-07-15
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [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 HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2XG66W44KF
Rxcui1111343

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
79903-001-39OLOPATADINE HYDROCHLORIDE2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.54
79903-001-39OLOPATADINE HYDROCHLORIDE1 in 1 CARTONSOLUTION14
79903-001-41OLOPATADINE HYDROCHLORIDE2 in 1 CARTONSOLUTION24
79903-001-41OLOPATADINE HYDROCHLORIDE2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79903-001-41ML - Milliliter79903-00193b7566e-a798-465c-9764-7273d4855cf612024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-001OLOPATADINE HYDROCHLORIDE SOLUTION [WAL-MART STORES, INC.]4Current NDC, Legacy NDC, 4 package rows20210927_34723580-dfd0-4ab7-a757-d86570261e7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSN34723580-dfd0-4ab7-a757-d86570261e7f4
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCD34723580-dfd0-4ab7-a757-d86570261e7f4
1111343olopatadine 0.2 % Ophthalmic SolutionSY34723580-dfd0-4ab7-a757-d86570261e7f4
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSY34723580-dfd0-4ab7-a757-d86570261e7f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
79903-001-39799030001391 BOTTLE, PLASTIC in 1 CARTON (79903-001-39) / 2.5 mL in 1 BOTTLE, PLASTIC2020-07-150000-00-00NoNoCurrent
79903-001-41799030001412 BOTTLE, PLASTIC in 1 CARTON (79903-001-41) / 2.5 mL in 1 BOTTLE, PLASTIC2020-07-150000-00-00NoNoCurrent