Tafluprost Ophthalmic Solution, 0.0015%

Manufacturer
The Ritedose Corporation
Effective date
2022-12-21
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:43:36

Label at a glance#

ProductTafluprost
Active ingredientTAFLUPROST
Label structure2 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 0781-6184-87

Tafluprost Ophthalmic Solution 0.0015%

Single-Use Containers

Preservative-Free, Sterile

For Topical Application in the Eye

REFRIGERATE (2° to 8°C or 36° to 46°F)

Rx Only

30 Single-Use Containers:

6 Pouches x 5 Single-Use Containers

(0.3 mL each)

Sandoz A Novartis Division

Tafluprost Ophthalmic Solution, 0.0015% Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tafluprost-30ct-cartontafluprost-30ct-carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65302-06265302-062-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
f05e2b3e-be98-5187-e053-2a95a90a1067f05e2b3e-be97-5187-e053-2a95a90a10672022-12-21Exact identifier
spl id: f05e2b3e-be98-5187-e053-2a95a90a1067
spl set id: f05e2b3e-be97-5187-e053-2a95a90a1067

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.