Home NDC 0781-6184 Tafluprost
Product NDC 0781-6184
11-digit product format 007816184
Labeler code 0781
Product ID 0781-6184_d105b545-530d-4a71-8e5a-903ab352c373
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tafluprost
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Sandoz Inc
Application ANDA209040
Marketing category ANDA
Marketing start 2022-12-05
Substance TAFLUPROST
Active strength .0045 mg/.3mL
Pharmacologic classes Increased Prostaglandin Activity [PE], Prostaglandin Analog [EPC], Prostaglandin Receptor Agonists [MoA], 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 43 .
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 A209040-001 TAFLUPROST TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209040-001 AT
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 2026-09-14 22:38:34 2026-08 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209040-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-28 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Tafluprost
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TAFLUPROST .0045 mg/.3mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1O6WQ6T7G3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1244611 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 0781-6184-14 Tafluprost 0.3 mL in 1 CONTAINER SOLUTION/ DROPS 0.3 12 0781-6184-14 Tafluprost 5 in 1 POUCH SOLUTION/ DROPS 5 12 0781-6184-87 Tafluprost 6 in 1 CARTON SOLUTION/ DROPS 6 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-6184 TAFLUPROST SOLUTION/ DROPS [SANDOZ INC] 11 Current NDC, Legacy NDC, 3 package rows 20221205_bfffa484-4105-45ec-ab1d-124e96639f35.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 0781-6184-14 00781618414 0.3 mL in 1 CONTAINER 0.3 ml Historical 0781-6184-87 00781618487 6 POUCH in 1 CARTON (0781-6184-87) / 5 CONTAINER in 1 POUCH (0781-6184-14) / .3 mL in 1 CONTAINER 6 pouch 2022-12-05 0000-00-00 No No Current