Home NDC 0378-9651 Travoprost Ophthalmic Solution, 0.004%
Product NDC 0378-9651
11-digit product format 003789651
Labeler code 0378
Product ID 0378-9651_d78c5705-68ac-4363-b9ae-5facc60e2b79
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Travoprost Ophthalmic Solution, 0.004%
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Mylan Pharmaceuticals Inc.
Application ANDA205050
Marketing category ANDA
Marketing start 2019-12-18
Substance TRAVOPROST
Active strength .04 mg/mL
Pharmacologic classes Prostaglandin Analog [EPC], Prostaglandins [CS]
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 A205050-001 TRAVOPROST TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 2017-07-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205050-001 AT2
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 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 2017-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 2017-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 2017-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 2017-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205050-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2017-07-07 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Travoprost Ophthalmic Solution, 0.004%
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRAVOPROST .04 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WJ68R08KX9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 284008 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 0378-9651-32 Travoprost Ophthalmic Solution, 0.004% 2.5 mL in 1 BOTTLE SOLUTION/ DROPS 2.5 7 0378-9651-32 Travoprost Ophthalmic Solution, 0.004% 1 in 1 CARTON SOLUTION/ DROPS 1 7 0378-9651-50 Travoprost Ophthalmic Solution, 0.004% 5 mL in 1 BOTTLE SOLUTION/ DROPS 5 7 0378-9651-50 Travoprost Ophthalmic Solution, 0.004% 1 in 1 CARTON SOLUTION/ DROPS 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-9651 TRAVOPROST OPHTHALMIC SOLUTION, 0.004% SOLUTION/ DROPS [MYLAN PHARMACEUTICALS INC.] 6 Current NDC, Legacy NDC, 4 package rows 20241116_00dc284f-fd96-423b-bb8f-b90ee13439bf.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 0378-9651-32 00378965132 1 BOTTLE in 1 CARTON (0378-9651-32) / 2.5 mL in 1 BOTTLE 1 bottle 2019-12-18 0000-00-00 No No Current 0378-9651-50 00378965150 1 BOTTLE in 1 CARTON (0378-9651-50) / 5 mL in 1 BOTTLE 1 bottle 2019-12-18 0000-00-00 No No Current