Home NDC 50742-339-30 Tafluprost
Product NDC 50742-339
Requested package NDC 50742-339-30
11-digit product format 507420339
Labeler code 50742
Product ID 50742-339_9ebbfaa4-b3c0-46d2-bc83-9817b2d238df
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tafluprost
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Ingenus Pharmaceuticals, LLC
Application ANDA218002
Marketing category ANDA
Marketing start 2024-12-18
Substance TAFLUPROST
Active strength .015 mg/mL
Pharmacologic classes Increased Prostaglandin Activity [PE], Prostaglandin Analog [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 3 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 2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50742-339 50742-339-30 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50742-339 50742-339-30 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50742-339 50742-339-30 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
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 A218002-001 TAFLUPROST TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2024-04-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218002-001 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 2026-02-19 14:30 UTC 2026-02 A218002-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2024-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218002-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2024-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218002-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2024-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218002-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2024-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218002-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2024-04-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218002-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2024-04-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218002-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC 2024-04-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218002-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC 2024-04-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218002-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC 2024-04-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218002-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC 2024-04-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218002-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC 2024-04-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218002-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC 2024-04-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218002-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC 2024-04-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218002-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2024-04-05 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218002-001 TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT 2024-04-05 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Tafluprost
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TAFLUPROST .015 mg/mL
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 50742-339-05 Tafluprost 0.3 mL in 1 VIAL, SINGLE-DOSE SOLUTION/ DROPS 0.3 7 50742-339-05 Tafluprost 5 in 1 POUCH SOLUTION/ DROPS 5 7 50742-339-30 Tafluprost 6 in 1 CARTON SOLUTION/ DROPS 6 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50742-339 TAFLUPROST SOLUTION/ DROPS [INGENUS PHARMACEUTICALS, LLC] 7 Current NDC, 3 package rows 20241219_5d766054-d13f-462c-bf8a-6462e56ca097.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 50742-339-30 50742033930 6 POUCH in 1 CARTON (50742-339-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH (50742-339-05) / .3 mL in 1 VIAL, SINGLE-DOSE 6 pouch 2024-12-18 No No Current