Home NDC 70382-204 DEXTENZA
Product NDC 70382-204
11-digit product format 703820204
Labeler code 70382
Product ID 70382-204_ad2305a4-f888-4800-a31e-1fff3ffee20d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dexamethasone
Dosage form INSERT
Route INTRACANALICULAR; OPHTHALMIC
Labeler Ocular Therapeutix, Inc.
Application NDA208742
Marketing category NDA
Marketing start 2019-01-07
Substance DEXAMETHASONE
Active strength .4 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 1 .
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 N208742-001 DEXTENZA DEXAMETHASONE 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208742-001 8563027 2030-02-12 U-2487 2019-01-30 N208742-001 8409606 2030-05-14 Drug product 2019-01-30 N208742-001 12150896 2036-10-07 U-1680 2024-12-17 N208742-001 12150896 2036-10-07 U-3455 2024-12-17 N208742-001 11458041 2037-11-16 U-1680 2022-10-20 N208742-001 11458041 2037-11-16 U-3455 2022-10-20 N208742-001 12144889 2041-04-26 U-1680 2024-12-17
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208742-001 NPP 2028-04-07
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.
Product history page 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208742-001 DEXTENZA 0.4MG INSERT / OPHTHALMIC RLD, RS 2018-11-30 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 5 · 188 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208742-001 8563027 2030-02-12 U-2487 2019-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208742-001 8409606 2030-05-14 Drug product 2019-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208742-001 12150896 2036-10-07 U-1680 2024-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208742-001 12150896 2036-10-07 U-3455 2024-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208742-001 11458041 2037-11-16 U-1680 2022-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208742-001 11458041 2037-11-16 U-3455 2022-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208742-001 12144889 2041-04-26 U-1680 2024-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208742-001 8563027 2030-02-12 U-2487 2019-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208742-001 8409606 2030-05-14 Drug product 2019-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208742-001 12150896 2036-10-07 U-1680 2024-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208742-001 12150896 2036-10-07 U-3455 2024-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208742-001 11458041 2037-11-16 U-1680 2022-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208742-001 11458041 2037-11-16 U-3455 2022-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208742-001 12144889 2041-04-26 U-1680 2024-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208742-001 8563027 2030-02-12 U-2487 2019-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208742-001 8409606 2030-05-14 Drug product 2019-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208742-001 12150896 2036-10-07 U-1680 2024-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208742-001 12150896 2036-10-07 U-3455 2024-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208742-001 11458041 2037-11-16 U-1680 2022-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208742-001 11458041 2037-11-16 U-3455 2022-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208742-001 12144889 2041-04-26 U-1680 2024-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208742-001 8563027 2030-02-12 U-2487 2019-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208742-001 8409606 2030-05-14 Drug product 2019-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208742-001 12150896 2036-10-07 U-1680 2024-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208742-001 12150896 2036-10-07 U-3455 2024-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208742-001 11458041 2037-11-16 U-1680 2022-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208742-001 11458041 2037-11-16 U-3455 2022-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208742-001 12144889 2041-04-26 U-1680 2024-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208742-001 8563027 2030-02-12 U-2487 2019-01-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208742-001 8409606 2030-05-14 Drug product 2019-01-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208742-001 12150896 2036-10-07 U-1680 2024-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208742-001 12150896 2036-10-07 U-3455 2024-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208742-001 11458041 2037-11-16 U-1680 2022-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208742-001 11458041 2037-11-16 U-3455 2022-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208742-001 12144889 2041-04-26 U-1680 2024-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208742-001 9254267 2024-09-11 Drug product 2019-01-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208742-001 8563027 2030-02-12 U-2487 2019-01-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208742-001 8409606 2030-05-14 Drug product 2019-01-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208742-001 12150896 2036-10-07 U-1680 2024-12-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208742-001 12150896 2036-10-07 U-3455 2024-12-17 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 58 observed states.
Additional Listing Data#
Finished product Yes
Brand name base DEXTENZA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXAMETHASONE .4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7S5I7G3JQL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2108015 Internal RxNorm lookup 2108020 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 70382-204-01 DEXTENZA 1 in 1 BOX, UNIT-DOSE INSERT 1 18 70382-204-10 DEXTENZA 10 in 1 BOX, UNIT-DOSE INSERT 10 18 70382-204-88 DEXTENZA 1 in 1 POUCH INSERT 1 18 70382-204-99 DEXTENZA 1 in 1 BOX, UNIT-DOSE INSERT 1 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70382-204 DEXTENZA (DEXAMETHASONE) INSERT [OCULAR THERAPEUTIX, INC.
] 17 Current NDC, Legacy NDC, 4 package rows 20250420_7514e6b8-c33f-4fbf-8810-ef520e1eb4bd.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 70382-204-01 70382020401 1 POUCH in 1 BOX, UNIT-DOSE (70382-204-01) / 1 INSERT in 1 POUCH (70382-204-88) 1 pouch 2019-01-07 0000-00-00 No No Current 70382-204-10 70382020410 10 POUCH in 1 BOX, UNIT-DOSE (70382-204-10) / 1 INSERT in 1 POUCH (70382-204-88) 10 pouch 2019-01-07 0000-00-00 No No Current 70382-204-88 70382020488 1 in 1 POUCH Historical 70382-204-99 70382020499 1 POUCH in 1 BOX, UNIT-DOSE (70382-204-99) / 1 INSERT in 1 POUCH (70382-204-88) 1 pouch 2019-01-07 0000-00-00 No No Current