FDA.reportPublic FDA data

OLOPATADINE HYDROCHLORIDE

Product NDC
68001-674
11-digit product format
680010674
Labeler code
68001
Product ID
68001-674_4ddbb9c6-87d6-317b-e063-6294a90a7375
Type
HUMAN OTC DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
BluePoint Laboratories
Application
ANDA219557
Marketing category
ANDA
Marketing start
2025-12-05
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
2 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219557-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2025-02-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A219557-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2025-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219557-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2025-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219557-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2025-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A219557-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2025-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A219557-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2025-02-28fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219557-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2025-02-28a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
OLOPATADINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLOPATADINE HYDROCHLORIDE2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2XG66W44KFInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1111343Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3e86783f-0001-625f-e063-6294a90acd20Available on FDA.report

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
68001-674-92OLOPATADINE HYDROCHLORIDE1 in 1 CARTONSOLUTION12
68001-674-92OLOPATADINE HYDROCHLORIDE2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-674-92ML - Milliliter68001-6740ef4909c-5b9b-43a7-b4f5-ece1ea8b985d12025-10-14

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye Allergy Itch ReliefEYE ALLERGY ITCH RELIEFAllegiant Healthb40bf37a-da62-4ef7-8722-33a3a0f67c642026-05-26WarningsExact identifier
application applno (ANDA): 219557
application number: ANDA219557
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEBluePoint Laboratories3e86783f-0001-625f-e063-6294a90acd202026-03-25WarningsExact identifier
application applno (ANDA): 219557
application number: ANDA219557
ndc (product): 68001-674
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAmerisourceBergen Drug Corp18f851e3-24c6-44fd-8376-0f5418ded9a92026-02-16WarningsExact identifier
application applno (ANDA): 219557
application number: ANDA219557
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEYYBA Corp47f8ae9b-d92b-4bcb-e063-6294a90af45a2026-02-03WarningsExact identifier
application applno (ANDA): 219557
application number: ANDA219557
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEGLENMARK THERAPEUTICS INC., USA07e8b359-d4ae-4b5b-81dc-c7e57e172c582026-01-27WarningsExact identifier
application applno (ANDA): 219557
application number: ANDA219557

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSN3e86783f-0001-625f-e063-6294a90acd202
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCD3e86783f-0001-625f-e063-6294a90acd202
1111343olopatadine 0.2 % Ophthalmic SolutionSY3e86783f-0001-625f-e063-6294a90acd202
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSY3e86783f-0001-625f-e063-6294a90acd202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68001-674-92680010674921 BOTTLE, PLASTIC in 1 CARTON (68001-674-92) / 2.5 mL in 1 BOTTLE, PLASTIC2025-12-05NoNoCurrent