Home NDC 0078-0946-40 Travatan Z
Product NDC 0078-0946
Requested package NDC 0078-0946-40
11-digit product format 000780946
Labeler code 0078
Product ID 0078-0946_a415f951-2153-4513-959e-2498229ef71f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name travoprost
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Novartis Pharmaceuticals Corporation
Application NDA021994
Marketing category NDA
Marketing start 2006-10-20
Marketing end 2026-10-31
Substance TRAVOPROST
Active strength .04 mg/mL
Pharmacologic classes Prostaglandin Analog [EPC], Prostaglandins [CS]
NDC exclude flag No
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0078-0946 0078-0946-40 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 N021994-001 TRAVATAN Z TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2006-09-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021994-001 AT2
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021994-001 8323630 2027-09-20 Drug product 2012-12-18 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 N021994-001 8268299 2029-10-13 Drug product 2012-09-24
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 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 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2006-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2006-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2006-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2006-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 4 · 123 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 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 8072bd15b7f6…
Additional Listing Data#
Finished product Yes
Brand name base Travatan Z 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 284008 Internal RxNorm lookup 285032 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 0078-0946-25 Travatan Z 5 mL in 1 BOTTLE SOLUTION/ DROPS 5 6 0078-0946-25 Travatan Z 1 in 1 CARTON SOLUTION/ DROPS 1 6 0078-0946-40 Travatan Z 1 in 1 CARTON SOLUTION/ DROPS 1 6 0078-0946-40 Travatan Z 2.5 mL in 1 BOTTLE SOLUTION/ DROPS 2.5 6 0078-0946-98 Travatan Z 2.5 mL in 1 BOTTLE SOLUTION/ DROPS 2.5 6 0078-0946-98 Travatan Z 1 in 1 CARTON SOLUTION/ DROPS 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0946 TRAVATAN Z (TRAVOPROST) SOLUTION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION] 4 Current NDC, Legacy NDC, 6 package rows 20230628_028455e0-ae77-4213-8819-3b58ef7d6a14.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.
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 0078-0946-40 00078094640 1 BOTTLE in 1 CARTON (0078-0946-40) / 2.5 mL in 1 BOTTLE 1 bottle 2020-09-04 2026-10-31 No No Current