Home NDC 42571-264 tafluprost
Product NDC 42571-264
11-digit product format 425710264
Labeler code 42571
Product ID 42571-264_4c55f162-175b-d458-e063-6394a90a066f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tafluprost opthalmic
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Micro Labs Limited
Application ANDA209051
Marketing category ANDA
Marketing start 2022-11-18
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 A209051-001 TAFLUPROST TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209051-001 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.
Product history page 1 of 2 · 42 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 2026-09-14 22:38:34 2026-08 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209051-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2019-08-19 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 42571-264-26 tafluprost 15 in 1 POUCH SOLUTION/ DROPS 15 6 42571-264-26 tafluprost 1 in 1 CARTON SOLUTION/ DROPS 1 6 42571-264-73 tafluprost 2 in 1 CARTON SOLUTION/ DROPS 2 6 42571-264-73 tafluprost 15 in 1 POUCH SOLUTION/ DROPS 15 6 42571-264-74 tafluprost 15 in 1 POUCH SOLUTION/ DROPS 15 6 42571-264-74 tafluprost 6 in 1 CARTON SOLUTION/ DROPS 6 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-264 TAFLUPROST (TAFLUPROST OPTHALMIC) SOLUTION/ DROPS [MICRO LABS LIMITED] 5 Current NDC, Legacy NDC, 6 package rows 20250112_fcaab8b3-3791-49ba-909e-a09651a30b33.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 42571-264-26 42571026426 1 POUCH in 1 CARTON (42571-264-26) / 15 VIAL in 1 POUCH / .3 mL in 1 VIAL 1 pouch 2022-11-18 0000-00-00 No No Current 42571-264-73 42571026473 2 POUCH in 1 CARTON (42571-264-73) / 15 VIAL in 1 POUCH / .3 mL in 1 VIAL 2 pouch 2022-11-18 0000-00-00 No No Current 42571-264-74 42571026474 6 POUCH in 1 CARTON (42571-264-74) / 15 VIAL in 1 POUCH / .3 mL in 1 VIAL 6 pouch 2022-11-18 0000-00-00 No No Current