Home NDC 68462-659 Ryaltris
Product NDC 68462-659
11-digit product format 684620659
Labeler code 68462
Product ID 68462-659_ecbea621-93b0-40ce-adce-1d304c4fdb15
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name olopatadine hydrochloride and mometasone furoate
Dosage form SPRAY, METERED
Route NASAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application NDA211746
Marketing category NDA
Marketing start 2026-01-13
Substance OLOPATADINE HYDROCHLORIDE; MOMETASONE FUROATE MONOHYDRATE
Active strength 665; 25 ug/1; ug/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], 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 43 .
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 N211746-001 RYALTRIS MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13
Orange Book patents# Current patent rows page 1 of 1 · 17 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211746-001 10016443 2034-09-04 U-3297 2022-02-11 N211746-001 10376526 2034-09-04 Drug product 2022-02-11 N211746-001 10517880 2034-09-04 U-3297 Drug product 2022-02-11 N211746-001 10548907 2034-09-04 U-3297 2022-02-11 N211746-001 10561672 2034-09-04 Drug product 2022-02-11 N211746-001 10646500 2034-09-04 U-3297 2022-02-11 N211746-001 10758550 2034-09-04 U-3296 2022-02-11 N211746-001 10765686 2034-09-04 U-3295 2022-02-11 N211746-001 11400101 2034-09-04 U-3297 2022-08-25 N211746-001 12064442 2034-09-04 U-3297 2024-09-12 N211746-001 9078923 2034-09-04 U-3297 Drug product 2022-02-11 N211746-001 9370483 2034-09-04 Drug product 2022-02-11 N211746-001 9750754 2034-09-04 U-3297 Drug product 2022-02-11 N211746-001 9937189 2034-09-04 Drug product 2022-02-11 N211746-001 11679210 2038-09-03 Drug product 2023-07-20 N211746-001 12303635 2039-04-08 Drug substance, Drug product 2025-06-06 N211746-001 12653833 2044-11-21 U-4564 Drug product 2026-07-09
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N211746-001 NPP 2029-07-07
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 2026-09-14 22:38:34 2026-08 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211746-001 RYALTRIS 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2022-01-13 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 12 · 467 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N211746-001 10016443 2034-09-04 U-3297 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211746-001 10376526 2034-09-04 Drug product 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211746-001 10517880 2034-09-04 U-3297 Drug product 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211746-001 10548907 2034-09-04 U-3297 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211746-001 10561672 2034-09-04 Drug product 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211746-001 10646500 2034-09-04 U-3297 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211746-001 10758550 2034-09-04 U-3296 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211746-001 10765686 2034-09-04 U-3295 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211746-001 11400101 2034-09-04 U-3297 2022-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211746-001 12064442 2034-09-04 U-3297 2024-09-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211746-001 9078923 2034-09-04 U-3297 Drug product 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211746-001 9370483 2034-09-04 Drug product 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211746-001 9750754 2034-09-04 U-3297 Drug product 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211746-001 9937189 2034-09-04 Drug product 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211746-001 11679210 2038-09-03 Drug product 2023-07-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211746-001 12303635 2039-04-08 Drug substance, Drug product 2025-06-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211746-001 12653833 2044-11-21 U-4564 Drug product 2026-07-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211746-001 10016443 2034-09-04 U-3297 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211746-001 10376526 2034-09-04 Drug product 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211746-001 10517880 2034-09-04 U-3297 Drug product 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211746-001 10548907 2034-09-04 U-3297 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211746-001 10561672 2034-09-04 Drug product 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211746-001 10646500 2034-09-04 U-3297 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211746-001 10758550 2034-09-04 U-3296 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211746-001 10765686 2034-09-04 U-3295 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211746-001 11400101 2034-09-04 U-3297 2022-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211746-001 12064442 2034-09-04 U-3297 2024-09-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211746-001 9078923 2034-09-04 U-3297 Drug product 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211746-001 9370483 2034-09-04 Drug product 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211746-001 9750754 2034-09-04 U-3297 Drug product 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211746-001 9937189 2034-09-04 Drug product 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211746-001 11679210 2038-09-03 Drug product 2023-07-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211746-001 12303635 2039-04-08 Drug substance, Drug product 2025-06-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211746-001 12653833 2044-11-21 U-4564 Drug product 2026-07-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211746-001 10016443 2034-09-04 U-3297 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211746-001 10376526 2034-09-04 Drug product 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211746-001 10517880 2034-09-04 U-3297 Drug product 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211746-001 10548907 2034-09-04 U-3297 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211746-001 10561672 2034-09-04 Drug product 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211746-001 10646500 2034-09-04 U-3297 2022-02-11 011fe1cb6892…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ryaltris
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLOPATADINE HYDROCHLORIDE 665 ug/1 MOMETASONE FUROATE MONOHYDRATE 25 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2XG66W44KF Internal UNII lookup MTW0WEG809 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2591806 Internal RxNorm lookup 2591812 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 68462-659-27 Ryaltris 12 in 1 BOX SPRAY, METERED 12 1 68462-659-27 Ryaltris 1 in 1 CARTON SPRAY, METERED 1 1 68462-659-84 Ryaltris 12 in 1 BOX SPRAY, METERED 12 1 68462-659-84 Ryaltris 1 in 1 CARTON SPRAY, METERED 1 1
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68462-659-27 68462065927 12 CARTON in 1 BOX (68462-659-27) / 1 BOTTLE, SPRAY in 1 CARTON / 240 SPRAY, METERED in 1 BOTTLE, SPRAY 12 carton 2026-01-13 No No Current 68462-659-84 68462065984 12 CARTON in 1 BOX (68462-659-84) / 1 BOTTLE, SPRAY in 1 CARTON / 56 SPRAY, METERED in 1 BOTTLE, SPRAY 12 carton 2026-01-13 No No Current