FDA.reportPublic FDA data

Olopatadine Hydrochloride

Product NDC
65162-890
11-digit product format
651620890
Labeler code
65162
Product ID
65162-890_270f118a-97b1-420b-8504-bfc600008903
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olopatadine Hydrochloride
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA210901
Marketing category
ANDA
Marketing start
2020-02-03
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
665 ug/1
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 HYDROCHLORIDE665 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2XG66W44KF
Rxcui1797895

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
65162-890-23Olopatadine Hydrochloride665 in 1 BOTTLE, SPRAYSPRAY, METERED66511
65162-890-23Olopatadine Hydrochloride1 in 1 CARTONSPRAY, METERED111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-890-23GM - Gram65162-89092b82a40-89b6-4127-9d15-4f32131c91e112021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-890OLOPATADINE HYDROCHLORIDE SPRAY, METERED [AMNEAL PHARMACEUTICALS LLC]11Current NDC, Legacy NDC, 2 package rows20241031_806e8d0f-ff42-4d6e-b840-49e3bf867cb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797895olopatadine HCl 665 MCG/ACTUAT Metered Dose Nasal SprayPSN806e8d0f-ff42-4d6e-b840-49e3bf867cb511
1797895olopatadine hydrochloride 0.665 MG/ACTUAT Metered Dose Nasal SpraySCD806e8d0f-ff42-4d6e-b840-49e3bf867cb511
1797895olopatadine hydrochloride 665 MCG/ACTUAT (equivalent to olopatadine 600 MCG/ACTUAT) Metered Dose Nasal SpraySY806e8d0f-ff42-4d6e-b840-49e3bf867cb511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-890-23651620890231 BOTTLE, SPRAY in 1 CARTON (65162-890-23) / 665 SPRAY, METERED in 1 BOTTLE, SPRAY2020-02-030000-00-00NoNoCurrent