Home NDC 63629-8434 olopatadine hydrochloride
Product NDC 63629-8434
11-digit product format 636298434
Labeler code 63629
Product ID 63629-8434_e659b3d5-5644-4372-a536-5034b9e85621
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olopatadine Hydrochloride
Dosage form SPRAY
Route NASAL
Labeler Bryant Ranch Prepack
Application ANDA202853
Marketing category ANDA
Marketing start 2017-06-14
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 A202853-001 OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202853-001 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 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202853-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2017-01-31 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 63629-8434-1 olopatadine hydrochloride 240 in 1 BOTTLE SPRAY 240 108 63629-8434-1 olopatadine hydrochloride 1 in 1 CARTON SPRAY 1 108
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-8434 OLOPATADINE HYDROCHLORIDE SPRAY [BRYANT RANCH PREPACK] 108 Current NDC, Legacy NDC, 2 package rows 20240814_272e8f56-ee4e-456f-ab98-3e40f657c630.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 · 3 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 63629-8434-1 63629843401 1 BOTTLE in 1 CARTON (63629-8434-1) / 240 SPRAY in 1 BOTTLE 1 bottle 2021-04-28 0000-00-00 No No Current