Home NDC 70069-586-01 Travoprost
Product NDC 70069-586
Requested package NDC 70069-586-01
11-digit product format 700690586
Labeler code 70069
Product ID 70069-586_080e6b52-e4d4-41d0-8100-7a8a4272012b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Travoprost (Isomer Free)
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Somerset Therapeutics, LLC
Application ANDA217228
Marketing category ANDA
Marketing start 2024-10-10
Substance TRAVOPROST
Active strength .04 mg/mL
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217228-001 TRAVOPROST TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 2024-09-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217228-001 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.
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 A217228-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 2024-09-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217228-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 2024-09-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217228-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 2024-09-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217228-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 2024-09-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217228-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2024-09-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217228-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2024-09-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217228-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2024-09-23 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217228-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2024-09-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217228-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT 2024-09-23 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217228-001 TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 2024-09-23 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Travoprost
Listing expiration 2026-12-31 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 70069-586-01 Travoprost 1 in 1 CARTON SOLUTION/ DROPS 1 4 70069-586-01 Travoprost 2.5 mL in 1 BOTTLE SOLUTION/ DROPS 2.5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70069-586 TRAVOPROST (TRAVOPROST (ISOMER FREE)) SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC] 4 Current NDC, 2 package rows 20241012_e9dd2388-afd3-4f40-b35d-54df8c239d29.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 Sample Exclude flag Status 70069-586-01 70069058601 1 BOTTLE in 1 CARTON (70069-586-01) / 2.5 mL in 1 BOTTLE 1 bottle 2024-10-10 No No Current