Tafluprost

Product NDC
65302-062
11-digit product format
653020062
Labeler code
65302
Product ID
65302-062_f05e2b3e-be98-5187-e053-2a95a90a1067
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tafluprost
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
The Ritedose Corporation
Application
ANDA209040
Marketing category
ANDA
Marketing start
2022-12-05
Marketing end
0000-00-00
Substance
TAFLUPROST
Active strength
0 mg/.3mL
Pharmacologic classes
Increased Prostaglandin Activity [PE], Prostaglandin Analog [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209040-001TAFLUPROSTTAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A209040-001AT

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-2884e616aacf4f…
2026-08-18 06:07:402026-07A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-284b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-28bb7c543d1eb4…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209040-001TAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICAT2022-01-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A209040-001AT184e616aacf4f…
2026-08-18 06:07:402026-07A209040-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209040-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209040-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209040-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209040-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209040-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209040-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209040-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209040-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209040-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209040-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209040-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209040-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209040-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209040-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209040-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209040-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209040-001AT14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A209040-001AT1bb7c543d1eb4…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209040-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209040-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209040-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209040-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209040-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209040-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209040-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209040-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209040-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209040-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209040-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209040-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209040-001AT1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209040-001AT1a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TafluprostTAFLUPROSTSandoz Incbfffa484-4105-45ec-ab1d-124e96639f352026-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209040
application number: ANDA209040

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65302-062-05653020062056 POUCH in 1 CARTON (65302-062-05) > 5 AMPULE in 1 POUCH > .3 mL in 1 AMPULE6 pouch2022-12-050000-00-00NoNoCurrent