ACUVUE Theravision with Ketotifen
- Product NDC
- 60123-019
- 11-digit product format
- 601230019
- Labeler code
- 60123
- Product ID
- 60123-019_194326a6-ec33-4dc6-89c8-5c8393b83c3d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketotifen fumarate
- Dosage form
- DRUG-ELUTING CONTACT LENS
- Route
- INTRAOCULAR
- Labeler
- Johnson & Johnson Vision Care, Inc.
- Application
- NDA022388
- Marketing category
- NDA
- Marketing start
- 2022-02-28
- Marketing end
- 0000-00-00
- Substance
- KETOTIFEN FUMARATE
- Active strength
- 0 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 60123-019 | I | Inactivated by FDA | 2026-08-11 | ||
| excluded package | package | 60123-019 | 60123-019-30 | I | Inactivated by FDA | 2026-08-11 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 60123-019-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 60123-019-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 60123-019-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 60123-019-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 60123-019-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 60123-019-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 60123-019-30 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 60123-019-30 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 60123-019-30 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 60123-019-30 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 60123-019-30 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 60123-019-30 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 60123-019-30 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 60123-019-30 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 60123-019-30 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | KETOTIFEN FUMARATE | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | |
| N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 |
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 | 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 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD, RS | 2022-02-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD, RS | 2022-02-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD, RS | 2022-02-25 | 4b0b4de00fa7… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD, RS | 2022-02-25 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD, RS | 2022-02-25 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD, RS | 2022-02-25 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD, RS | 2022-02-25 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD, RS | 2022-02-25 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD, RS | 2022-02-25 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N022388-001 | ACUVUE THERAVISION WITH KETOTIFEN | EQ 19MCG BASE | DRUG-ELUTING CONTACT LENS / OPHTHALMIC | RLD | 2022-02-25 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | 5d02ea3f76ae… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022388-001 | 9474746 | 2028-03-27 | Drug product | 2022-03-23 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022388-001 | 9962376 | 2030-06-27 | Drug product | 2022-03-23 | a72a2bbeb626… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022388-001 | NP | 2025-02-25 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022388-001 | NP | 2025-02-25 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022388-001 | NP | 2025-02-25 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022388-001 | NP | 2025-02-25 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022388-001 | NP | 2025-02-25 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022388-001 | NP | 2025-02-25 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022388-001 | NP | 2025-02-25 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022388-001 | NP | 2025-02-25 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022388-001 | NP | 2025-02-25 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022388-001 | NP | 2025-02-25 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022388-001 | NP | 2025-02-25 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022388-001 | NP | 2025-02-25 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022388-001 | NP | 2025-02-25 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022388-001 | NP | 2025-02-25 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022388-001 | NP | 2025-02-25 | 5d02ea3f76ae… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022388-001 | NP | 2025-02-25 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022388-001 | NP | 2025-02-25 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022388-001 | NP | 2025-02-25 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022388-001 | NP | 2025-02-25 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022388-001 | NP | 2025-02-25 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022388-001 | NP | 2025-02-25 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022388-001 | NP | 2025-02-25 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022388-001 | NP | 2025-02-25 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022388-001 | NP | 2025-02-25 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022388-001 | NP | 2025-02-25 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022388-001 | NP | 2025-02-25 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N022388-001 | NP | 2025-02-25 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022388-001 | NP | 2025-02-25 | cb3db0bc1861… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fa9ae9d1-ed96-4d6e-8814-0a4815bc3229 | Product name | 1 | 20221208 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 60123-019-30 | 2024-01-30 | C162847 | 48780-1 | 1030e365-38dd-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ACUVUE® THERAVISION™ WITH KETOTIFEN safely and effectively. See full prescribing information for ACUVUE® THERAVISION™ WITH KETOTIFEN. ACUVUE ® THERAVISION™ WITH KETOTIFEN (etafilcon A drug-eluting contact lens with ketotifen), for ophthalmic use Initial U.S. Approval: 2022 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60123-019-30 | ACUVUE Theravision with Ketotifen | 30 in 1 CARTON | drug-eluting contact lens | 30 | 2 | |
| 60123-019-30 | ACUVUE Theravision with Ketotifen | 1 in 1 BLISTER PACK | drug-eluting contact lens | 1 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2604049 | ACUVUE Theravision 19 MCG Drug-Eluting Contact Lens | PSN | d222d68c-911e-48a9-9bde-a1ca7e992d18 | 2 |
| 2604045 | ketotifen 19 MG Drug-Eluting Contact Lens | PSN | d222d68c-911e-48a9-9bde-a1ca7e992d18 | 2 |
| 2604049 | ketotifen 0.019 MG Drug-Eluting Contact Lens [Acuvue Theravision] | SBD | d222d68c-911e-48a9-9bde-a1ca7e992d18 | 2 |
| 2604045 | ketotifen 0.019 MG Drug-Eluting Contact Lens | SCD | d222d68c-911e-48a9-9bde-a1ca7e992d18 | 2 |
| 2604049 | Acuvue Theravision 0.019 MG Drug-Eluting Contact Lens | SY | d222d68c-911e-48a9-9bde-a1ca7e992d18 | 2 |
| 2604049 | Acuvue Theravision 19 MCG Drug-Eluting Contact Lens | SY | d222d68c-911e-48a9-9bde-a1ca7e992d18 | 2 |
| 2604045 | ketotifen 19 MG (as ketotifen fumarate 43 MCG) Drug-Eluting Contact Lens | SY | d222d68c-911e-48a9-9bde-a1ca7e992d18 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 60123-019-30 | 60123001930 | 30 BLISTER PACK in 1 CARTON (60123-019-30) > 1 DRUG-ELUTING CONTACT LENS in 1 BLISTER PACK | 30 blister pack | 2022-02-28 | 0000-00-00 | No | No | Current |