ZYMAXID
- Product NDC
- 0023-3615
- 11-digit product format
- 000233615
- Labeler code
- 0023
- Product ID
- 0023-3615_8ecbdc67-bc68-4437-b99d-9924e25dfe67
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gatifloxacin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Allergan, Inc.
- Application
- NDA022548
- Marketing category
- NDA
- Marketing start
- 2010-05-19
- Substance
- GATIFLOXACIN
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Quinolone Antimicrobial [EPC], Quinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022548-001 | ZYMAXID | GATIFLOXACIN | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022548-001 | 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 | 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 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022548-001 | ZYMAXID | 0.5% | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 2010-05-18 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022548-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022548-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022548-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022548-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022548-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022548-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022548-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022548-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022548-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022548-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022548-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022548-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022548-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022548-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022548-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022548-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022548-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022548-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022548-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022548-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022548-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022548-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022548-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022548-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022548-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022548-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022548-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022548-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022548-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022548-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022548-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022548-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022548-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022548-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022548-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022548-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022548-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022548-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N022548-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022548-001 | AT | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ZYMAXID
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GATIFLOXACIN | 5 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L4618BD7KJ | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1160b16c-929a-4e85-9c0b-1d8c96a7678b | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0023-3615-01 | ZYMAXID | 1 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 1 | 11 | |
| 0023-3615-01 | ZYMAXID | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 11 | |
| 0023-3615-25 | ZYMAXID | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 11 | |
| 0023-3615-25 | ZYMAXID | 2.5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 2.5 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0023-3615-25 | ML - Milliliter | 0023-3615 | 251b6de4-ffb3-4f38-a62c-f0820850fab6 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ZYMAXID | GATIFLOXACIN | Allergan, Inc. | 1160b16c-929a-4e85-9c0b-1d8c96a7678b | 2016-09-08 | Warnings, Adverse reactions | 022548 NDA022548 0023-3615 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 992395 | gatifloxacin 0.5 % Ophthalmic Solution | PSN | 1160b16c-929a-4e85-9c0b-1d8c96a7678b | 11 |
| 992399 | ZYMAXID 0.5 % Ophthalmic Solution | PSN | 1160b16c-929a-4e85-9c0b-1d8c96a7678b | 11 |
| 992399 | gatifloxacin 5 MG/ML Ophthalmic Solution [Zymaxid] | SBD | 1160b16c-929a-4e85-9c0b-1d8c96a7678b | 11 |
| 992395 | gatifloxacin 5 MG/ML Ophthalmic Solution | SCD | 1160b16c-929a-4e85-9c0b-1d8c96a7678b | 11 |
| 992395 | gatifloxacin 0.5 % Ophthalmic Solution | SY | 1160b16c-929a-4e85-9c0b-1d8c96a7678b | 11 |
| 992399 | Zymaxid 0.5 % Ophthalmic Solution | SY | 1160b16c-929a-4e85-9c0b-1d8c96a7678b | 11 |
| 992399 | Zymaxid 5 MG/ML Ophthalmic Solution | SY | 1160b16c-929a-4e85-9c0b-1d8c96a7678b | 11 |
| 992395 | gatifloxacin 0.5 % Ophthalmic Solution | PSN | 218fba79-c773-482d-90aa-7cf678694c36 | 2 |
| 992399 | ZYMAXID 0.5 % Ophthalmic Solution | PSN | 218fba79-c773-482d-90aa-7cf678694c36 | 2 |
| 992399 | gatifloxacin 5 MG/ML Ophthalmic Solution [Zymaxid] | SBD | 218fba79-c773-482d-90aa-7cf678694c36 | 2 |
| 992395 | gatifloxacin 5 MG/ML Ophthalmic Solution | SCD | 218fba79-c773-482d-90aa-7cf678694c36 | 2 |
| 992395 | gatifloxacin 0.5 % Ophthalmic Solution | SY | 218fba79-c773-482d-90aa-7cf678694c36 | 2 |
| 992399 | Zymaxid 0.5 % Ophthalmic Solution | SY | 218fba79-c773-482d-90aa-7cf678694c36 | 2 |
| 992399 | Zymaxid 5 MG/ML Ophthalmic Solution | SY | 218fba79-c773-482d-90aa-7cf678694c36 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0023-3615-01 | 00023361501 | 1 BOTTLE, DROPPER in 1 CARTON (0023-3615-01) / 1 mL in 1 BOTTLE, DROPPER | 2010-05-19 | 0000-00-00 | Yes | No | Current |
| 0023-3615-25 | 00023361525 | 1 BOTTLE, DROPPER in 1 CARTON (0023-3615-25) / 2.5 mL in 1 BOTTLE, DROPPER | 2010-05-19 | 0000-00-00 | No | No | Current |