Travoprost Ophthalmic Solution

Product NDC
63629-8839
11-digit product format
636298839
Labeler code
63629
Product ID
63629-8839_5aaef444-7e65-4ce9-8435-c82502e8b22c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
travoprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bryant Ranch Prepack
Application
NDA021994
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-12-18
Marketing end
0000-00-00
Substance
TRAVOPROST
Active strength
0 mg/mL
Pharmacologic classes
Prostaglandin Analog [EPC], Prostaglandins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-8839DDiscontinued by firm2026-08-11
excluded packagepackage63629-883963629-8839-1DDiscontinued by firm2026-08-11

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
N021994-001TRAVATAN ZTRAVOPROST0.004%SOLUTION/DROPS / OPHTHALMICAT2RLD, RS2006-09-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N021994-001AT2

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021994-00183236302027-09-20Drug product2012-12-18
N021994-00183889412027-09-20Drug product2013-03-08
N021994-00182682992029-10-13Drug product2012-09-24

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICAT2RLD, RS2006-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICAT2RLD, RS2006-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICAT2RLD, RS2006-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICAT2RLD, RS2006-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-2187673890dc5c…
2021-03-12 10:30 UTC2021-03N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-213f01610625f2…
2019-09-15 20:21 UTC2019-09N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21b00525d2431f…
2019-07-19 19:46 UTC2019-07N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-213f0d92c62455…
2023-05-13 08:27 UTC2023-05N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21053a50430f4f…
2023-01-26 05:58 UTC2023-01N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021994-001AT21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021994-001AT2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021994-001AT216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021994-001AT21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021994-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021994-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021994-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021994-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021994-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021994-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021994-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021994-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021994-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021994-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021994-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021994-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021994-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021994-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021994-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021994-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021994-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N021994-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021994-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021994-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021994-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N021994-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021994-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021994-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021994-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021994-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021994-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021994-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021994-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021994-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021994-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021994-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021994-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021994-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021994-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021994-001AT1cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021994-00183236302027-09-20Drug product2012-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021994-00183889412027-09-20Drug product2013-03-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021994-00182682992029-10-13Drug product2012-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021994-00183236302027-09-20Drug product2012-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021994-00183889412027-09-20Drug product2013-03-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021994-00182682992029-10-13Drug product2012-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021994-00183236302027-09-20Drug product2012-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021994-00183889412027-09-20Drug product2013-03-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021994-00182682992029-10-13Drug product2012-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021994-00183236302027-09-20Drug product2012-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021994-00183889412027-09-20Drug product2013-03-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021994-00182682992029-10-13Drug product2012-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021994-00183236302027-09-20Drug product2012-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021994-00183889412027-09-20Drug product2013-03-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021994-00182682992029-10-13Drug product2012-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021994-00183236302027-09-20Drug product2012-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021994-00183889412027-09-20Drug product2013-03-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021994-00182682992029-10-13Drug product2012-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021994-00183236302027-09-20Drug product2012-12-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021994-00183889412027-09-20Drug product2013-03-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021994-00182682992029-10-13Drug product2012-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021994-00183236302027-09-20Drug product2012-12-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021994-00183889412027-09-20Drug product2013-03-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021994-00182682992029-10-13Drug product2012-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021994-00183236302027-09-20Drug product2012-12-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021994-00183889412027-09-20Drug product2013-03-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021994-00182682992029-10-13Drug product2012-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021994-00183236302027-09-20Drug product2012-12-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N021994-00183889412027-09-20Drug product2013-03-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N021994-00182682992029-10-13Drug product2012-09-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021994-00183236302027-09-20Drug product2012-12-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021994-00183889412027-09-20Drug product2013-03-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021994-00182682992029-10-13Drug product2012-09-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021994-00183236302027-09-20Drug product2012-12-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021994-00183889412027-09-20Drug product2013-03-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021994-00182682992029-10-13Drug product2012-09-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021994-00183236302027-09-20Drug product2012-12-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021994-00183889412027-09-20Drug product2013-03-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021994-00182682992029-10-13Drug product2012-09-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021994-00183236302027-09-20Drug product2012-12-188072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
c9a16692-b67d-fe7d-e549-d5c422428aa8Product name520250305
d244df75-ee9e-4580-9b0c-1e61287c8253Product name120250102
52ddd23e-485b-499f-9fa1-f86549f4d9c0Product name220200605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8839-1ML - Milliliter63629-883917d446dc-687e-4869-b866-39a5f88661d512021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8839TRAVOPROST OPHTHALMIC SOLUTION (TRAVOPROST) SOLUTION/ DROPS [BRYANT RANCH PREPACK]102Legacy NDC20240116_b312cb27-199f-4d45-83f5-c3837ecb0a1a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Travatan ZTRAVOPROSTSandoz Inc4b5cffb0-74e0-44e4-8e18-f5d56e9db4502025-01-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 021994
application number: NDA021994
Travatan ZTRAVOPROSTNovartis Pharmaceuticals Corporation028455e0-ae77-4213-8819-3b58ef7d6a142023-06-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 021994
application number: NDA021994

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8839-1636298839011 BOTTLE in 1 CARTON (63629-8839-1) > 5 mL in 1 BOTTLE1 bottle2021-09-100000-00-00NoNoCurrent