Home NDC 60505-0845 Olopatadine Hydrochloride
Product NDC 60505-0845
11-digit product format 605050845
Labeler code 60505
Product ID 60505-0845_312454d0-6465-c4c7-991b-4c4e3bda33c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name olopatadine hydrochloride
Dosage form SPRAY, METERED
Route NASAL
Labeler Apotex Corp.
Application ANDA091572
Marketing category ANDA
Marketing start 2014-10-27
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091572-001 OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091572-001 AB
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.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091572-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2014-10-08 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Olopatadine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLOPATADINE HYDROCHLORIDE 665 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2XG66W44KF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1797895 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-0845-5 Olopatadine Hydrochloride 240 in 1 BOTTLE SPRAY, METERED 240 12 60505-0845-5 Olopatadine Hydrochloride 1 in 1 CARTON SPRAY, METERED 1 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Olopatadine Hydrochloride ACTIVE INGREDIENT 2XG66W44KF OLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.] 2 Olopatadine ACTIVE MOIETY D27V6190PM OLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.] 2 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 OLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K OLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.] 2 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB OLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X OLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I OLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.] 2 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 OLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R OLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-0845 OLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.] 11 Current NDC, Legacy NDC, 2 package rows 20240929_3aa27224-7b72-38eb-0c21-b8d73525ee85.zip
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60505-0845-5 60505084505 1 BOTTLE in 1 CARTON (60505-0845-5) / 240 SPRAY, METERED in 1 BOTTLE 1 bottle 2014-10-27 0000-00-00 No No Current