DURYSTA

Product NDC
0023-9652
11-digit product format
000239652
Labeler code
0023
Product ID
0023-9652_0315cd41-0cc8-44c3-82fc-501832cdb855
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bimatoprost
Dosage form
IMPLANT
Route
INTRACAMERAL
Labeler
Allergan, Inc.
Application
NDA211911
Marketing category
NDA
Marketing start
2020-03-04
Substance
BIMATOPROST
Active strength
10 ug/1
Pharmacologic classes
Prostaglandin Analog [EPC], Prostaglandins [CS]
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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N211911-001DURYSTABIMATOPROST10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-04

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N211911-001104415432026-12-19Drug product2020-03-24
N211911-00191494282026-12-19Drug product2020-03-24
N211911-00182067372027-04-07U-27592020-03-24
N211911-00177993362029-04-24Drug product2020-03-24
N211911-00186291852031-07-15Drug substance, Drug product2020-03-24
N211911-00194923162034-10-31Drug product2020-03-24
N211911-00199809742034-10-31U-27592020-03-24

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-044b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-0487673890dc5c…
2021-03-12 10:30 UTC2021-03N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-04c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-043f0d92c62455…
2023-05-13 08:27 UTC2023-05N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-04053a50430f4f…
2023-01-26 05:58 UTC2023-01N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-04cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N211911-001DURYSTA10MCGIMPLANT / OPHTHALMICRLD, RS2020-03-04a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 9 · 327 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N211911-001104415432026-12-19Drug product2020-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211911-00191494282026-12-19Drug product2020-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211911-00182067372027-04-07U-27592020-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211911-00177993362029-04-24Drug product2020-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211911-00186291852031-07-15Drug substance, Drug product2020-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211911-00194923162034-10-31Drug product2020-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211911-00199809742034-10-31U-27592020-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211911-00186733412025-02-19U-27592020-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211911-001104415432026-12-19Drug product2020-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211911-00191494282026-12-19Drug product2020-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211911-00182067372027-04-07U-27592020-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211911-00177993362029-04-24Drug product2020-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211911-00186291852031-07-15Drug substance, Drug product2020-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211911-00194923162034-10-31Drug product2020-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211911-00199809742034-10-31U-27592020-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N211911-00186733412025-02-19U-27592020-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211911-001104415432026-12-19Drug product2020-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211911-00191494282026-12-19Drug product2020-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211911-00182067372027-04-07U-27592020-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211911-00177993362029-04-24Drug product2020-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211911-00186291852031-07-15Drug substance, Drug product2020-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211911-00194923162034-10-31Drug product2020-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211911-00199809742034-10-31U-27592020-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211911-00186733412025-02-19U-27592020-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211911-001104415432026-12-19Drug product2020-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211911-00191494282026-12-19Drug product2020-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211911-00182067372027-04-07U-27592020-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211911-00177993362029-04-24Drug product2020-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211911-00186291852031-07-15Drug substance, Drug product2020-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211911-00194923162034-10-31Drug product2020-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211911-00199809742034-10-31U-27592020-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211911-00186733412025-02-19U-27592020-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211911-001104415432026-12-19Drug product2020-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211911-00191494282026-12-19Drug product2020-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211911-00182067372027-04-07U-27592020-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211911-00177993362029-04-24Drug product2020-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211911-00186291852031-07-15Drug substance, Drug product2020-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211911-00194923162034-10-31Drug product2020-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211911-00199809742034-10-31U-27592020-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211911-001103987072024-04-30U-27592020-03-2403ed91905a0d…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211911-001NP2023-03-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N211911-001NP2023-03-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N211911-001NP2023-03-044b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N211911-001NP2023-03-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N211911-001NP2023-03-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N211911-001NP2023-03-0487673890dc5c…
2021-03-12 10:30 UTC2021-03N211911-001NP2023-03-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N211911-001NP2023-03-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11N211911-001NP2023-03-04c0c555d07b60…
2023-12-20 04:57 UTC2023-12N211911-001NP2023-03-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N211911-001NP2023-03-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N211911-001NP2023-03-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N211911-001NP2023-03-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N211911-001NP2023-03-043f0d92c62455…
2023-05-13 08:27 UTC2023-05N211911-001NP2023-03-04053a50430f4f…
2023-01-26 05:58 UTC2023-01N211911-001NP2023-03-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N211911-001NP2023-03-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N211911-001NP2023-03-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N211911-001NP2023-03-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N211911-001NP2023-03-04cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
DURYSTA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIMATOPROST10 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QXS94885MZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2286602Internal RxNorm lookup
2286607Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3f59da84-0bcc-4c84-b3e2-e215681ef341Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f71952f0-5c3a-ff37-f1fb-fed3868f6302Product name820260105
546f403c-5466-48b9-a79e-80b68d2b77d8Product name120200706
3471d048-4165-432e-a2dc-905eb43247dbProduct name420200611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-9652-01DURYSTA1 in 1 POUCHIMPLANT115
0023-9652-03DURYSTA1 in 1 POUCHIMPLANT115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-9652-01EA - Each0023-965281c585ed-b81d-4141-a792-a5540e77993612020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-9652DURYSTA (BIMATOPROST) IMPLANT [ALLERGAN, INC.]15Current NDC, Legacy NDC, 2 package rows20250216_3f59da84-0bcc-4c84-b3e2-e215681ef341.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DURYSTABIMATOPROSTAllergan, Inc.3f59da84-0bcc-4c84-b3e2-e215681ef3412024-10-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 211911
application number: NDA211911
ndc (product): 0023-9652

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2286602bimatoprost 10 MCG Intracameral ImplantPSN3f59da84-0bcc-4c84-b3e2-e215681ef34115
2286607DURYSTA 10 MCG Intracameral ImplantPSN3f59da84-0bcc-4c84-b3e2-e215681ef34115
2286607bimatoprost 0.01 MG Drug Implant [Durysta]SBD3f59da84-0bcc-4c84-b3e2-e215681ef34115
2286602bimatoprost 0.01 MG Drug ImplantSCD3f59da84-0bcc-4c84-b3e2-e215681ef34115
2286602bimatoprost 10 MCG Drug ImplantSY3f59da84-0bcc-4c84-b3e2-e215681ef34115
2286607Durysta 10 MCG Drug ImplantSY3f59da84-0bcc-4c84-b3e2-e215681ef34115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0023-9652-01000239652011 IMPLANT in 1 POUCH (0023-9652-01) 1 implant2020-03-040000-00-00NoNoCurrent
0023-9652-03000239652031 IMPLANT in 1 POUCH (0023-9652-03) 1 implant2020-03-040000-00-00YesNoCurrent