Application 010496
- Type
- NDA
- Sponsor
- ASTRAZENECA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | LIDOCAINE HYDROCHLORIDE | INJECTABLE;SPINAL | 5% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | LIDOCAINE HYDROCHLORIDE | 5% | INJECTABLE / SPINAL | 1982-07-07 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N010496-002 | XYLOCAINE 5% W/ GLUCOSE 7.5% | 5% | INJECTABLE / SPINAL | 1982-07-07 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Bactine Max Dry | LIDOCAINE HYDROCHLORIDE | WellSpring Pharmaceutical Corporation | 466404cd-c46a-4944-b1ac-3b3b17f436a1 | 2022-12-27 | Warnings | LIDOCAINE HYDROCHLORIDE |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | B. Braun Medical Inc. | e0e479e6-4c94-44d0-8074-d0ee7b2bde22 | 2022-10-13 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Asclemed USA, Inc. | fecd1797-7757-4da8-b3a1-24b258634243 | 2022-10-12 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Asclemed USA, Inc. | 8ae0656c-36fb-48fb-886b-1031d11da552 | 2022-10-12 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Asclemed USA, Inc. | deec52c7-ebcf-422e-beab-bc1df2fe30cb | 2022-10-12 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidotran | LIDOCAINE HYDROCHLORIDE | PureTek Corporation | cf715e54-c413-1e8f-e053-2995a90a076d | 2022-09-19 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Novitium Pharma LLC | ffb2d794-2c88-48a2-beff-d01b6fcea51f | 2022-03-25 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lydexa 4.12% | LIDOCAINE HYDROCHLORIDE | PureTek Corporation | aa1c9d39-1283-8c6b-e053-2a95a90af5b5 | 2022-03-02 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | International Medication Systems, Limited | 2c48cfac-81eb-4a81-8590-bc94574dd4c3 | 2021-12-14 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Xylocaine | LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE | Fresenius Kabi USA, LLC | ba082c2f-64f4-419d-9c88-74f203316e17 | 2021-08-25 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine hydrochloride | LIDOCAINE HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | 6702589d-6a15-40fe-877a-a9a1a4ad0f7a | 2020-11-30 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine hydrochloride | LIDOCAINE HYDROCHLORIDE | Proficient Rx LP | 5b4b36dd-da60-47de-a2c1-517a52ab3549 | 2020-05-01 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Asclemed USA, Inc. | b8803e38-fe30-48ec-9399-013f2880e0eb | 2020-04-09 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| DermacinRx Lidotral | LIDOCAINE HYDROCHLORIDE | PureTek Corporation | 23efec58-67cc-418d-85f5-7ef156443cbf | 2019-02-04 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Eha | LIDOCAINE HYDROCHLORIDE | Asclemed USA, Inc. | 09835640-55c3-4bfa-9ad3-15d37f06e871 | 2018-11-01 | Warnings | LIDOCAINE HYDROCHLORIDE |
| SunBurnt PLUS Pain Relief | LIDOCAINE HYDROCHLORIDE | Welmedix LLC dba Welmedix Consumer Healthcare | 6363c695-f801-407d-a4e1-b0d9cfa0a273 | 2018-03-13 | Warnings | LIDOCAINE HYDROCHLORIDE |
| FSK-5 | LIDOCAINE HYDROCHLORIDE | Water-Jel Technologies | 4c62196a-9f94-4823-b95f-447f012f10bf | 2017-12-07 | Warnings | LIDOCAINE HYDROCHLORIDE |
| EBSS-5 | LIDOCAINE HYDROCHLORIDE | Water-Jel Technologies | 7e21b96a-3d89-4d1c-9ec6-0611f6c9c625 | 2017-12-07 | Warnings | LIDOCAINE HYDROCHLORIDE |
| IWK-5 | LIDOCAINE HYDROCHLORIDE | Water-Jel Technologies | f291841e-ccbd-4f5a-b1de-4cf596a167e3 | 2017-12-07 | Warnings | LIDOCAINE HYDROCHLORIDE |
| EBSL-5 | LIDOCAINE HYDROCHLORIDE | Water-Jel Technologies | 0d2631c1-93fc-478c-afed-0f175a7e8555 | 2017-12-07 | Warnings | LIDOCAINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.