Home NDC 65162-890 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 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 A210901-001 OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210901-001 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.
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 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2020-01-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2020-01-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2020-01-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2020-01-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2020-01-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2020-01-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL 2020-01-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2020-01-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2020-01-28 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2020-01-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2020-01-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2020-01-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2020-01-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2020-01-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB 2020-01-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210901-001 OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED / NASAL AB RS 2020-01-28 a50c72e98297…
Observed Orange Book normalized TE history# 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 65162-890-23 Olopatadine Hydrochloride 665 in 1 BOTTLE, SPRAY SPRAY, METERED 665 11 65162-890-23 Olopatadine Hydrochloride 1 in 1 CARTON SPRAY, METERED 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-890 OLOPATADINE HYDROCHLORIDE SPRAY, METERED [AMNEAL PHARMACEUTICALS LLC] 11 Current NDC, Legacy NDC, 2 package rows 20241031_806e8d0f-ff42-4d6e-b840-49e3bf867cb5.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 Marketing start Marketing end Sample Exclude flag Status 65162-890-23 65162089023 1 BOTTLE, SPRAY in 1 CARTON (65162-890-23) / 665 SPRAY, METERED in 1 BOTTLE, SPRAY 2020-02-03 0000-00-00 No No Current