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 | Medical Purchasing Solutions, LLC | 6bcdbee5-014e-6b4c-e053-2a91aa0aecd2 | 2023-05-30 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 8968c61e-2686-0fe6-e053-2a95a90a15fa | 2023-05-23 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 858f3faa-e56e-51f9-e053-2a91aa0aa721 | 2023-05-23 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 6bdd64a8-b90e-57d4-e053-2a91aa0a3911 | 2023-05-22 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 6947af02-f4e0-7f9c-e053-2a91aa0a45cd | 2023-05-22 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 86083fea-c064-4ef7-e053-2a91aa0ac17c | 2023-05-16 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 86093c75-6dde-bb16-e053-2991aa0ab6ef | 2023-05-16 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 79798b21-026d-1b4c-e053-2a91aa0a0129 | 2023-05-16 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 89691444-7bfb-3314-e053-2a95a90a268e | 2023-05-15 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 9c9655fd-89a9-77c8-e053-2a95a90a0c99 | 2023-05-15 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 9e412b4c-e24f-69ea-e053-2995a90ac600 | 2023-05-10 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 9e049bbe-0f4d-988e-e053-2a95a90a3691 | 2023-05-10 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | b63614eb-8776-4cd0-e053-2995a90a8f82 | 2023-05-04 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | c8e7f9ef-1982-b8ce-e053-2a95a90ac4ee | 2023-04-27 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | c8e8b217-a183-0d91-e053-2a95a90a4a44 | 2023-04-25 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| PharmapureRx Lidocaine HCl 4.12% | LIDOCAINE HYDROCHLORIDE | PureTek Corporation | b7a77ad1-821b-4388-a97c-aadb1340c536 | 2023-01-11 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | International Medication Systems, Limited | 5d3e9984-cef9-46f2-a6c9-3be8b26f45b3 | 2022-12-29 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.