Application 018967
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 200MG/100ML | No | No |
| 002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 400MG/100ML | No | No |
| 003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 800MG/100ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | ||
| N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | ||
| N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 79d66fd596c7… |
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 |
|---|---|---|---|---|---|---|
| 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 |
| Unburn | LIDOCAINE HYDROCHLORIDE | Water-Jel Technologies | 0c504ba8-8a40-43dd-8c68-62ed106b32a2 | 2017-12-01 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Unburn | LIDOCAINE HYDROCHLORIDE | Water-Jel Technologies | 40164231-1556-4714-9e27-9d41e3c71447 | 2017-11-30 | Warnings | LIDOCAINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.