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 | Aurobindo Pharma Limited | ab461805-413a-4fb3-88a1-224e1c423084 | 2025-07-30 | Boxed warning, Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll On | LIDOCAINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | 7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c4 | 2025-07-11 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 845b96c1-36a3-431f-8316-112ae881d934 | 2025-07-07 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | Henry Schein, Inc. | 767374af-89d1-4c19-bd8e-480699b45cf7 | 2025-06-11 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Burn | LIDOCAINE HYDROCHLORIDE | J&A Digital Inc. | d4b09055-b93e-466f-9e24-cae098af6e24 | 2025-06-02 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Xylocaine | LIDOCAINE HYDROCHLORIDE | Asclemed USA, Inc. | 25370b0f-0ac6-4a03-abe6-d73d65192180 | 2025-05-31 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine hydrochloride | LIDOCAINE HYDROCHLORIDE | ATLANTIC BIOLOGICALS CORP. | 75d17334-6876-42d0-8a02-82669d139e4f | 2025-05-12 | Boxed warning, Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Huons Co., Ltd. | 8ec2d256-fc4f-44f6-bee2-eef2bf3bf580 | 2025-05-09 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 5523fdfe-69fd-49a5-b51f-73e2223d49a9 | 2025-05-01 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Xylocaine | LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE | Fresenius Kabi USA, LLC | 4dd52202-8eef-4136-92dd-ada573b7cf74 | 2025-04-22 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | Xttrium Laboratories, Inc. | 31a5a48e-27d7-90f3-e063-6294a90a2d9e | 2025-03-31 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | cddb2b22-fce3-8967-6e54-dca3df5ac4b3 | 2025-03-26 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | abf60c5c-66df-4894-aa8f-bf770a6e9d00 | 2025-03-24 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine hydrochloride | LIDOCAINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 037764d3-da0e-5ebb-e063-6294a90ab6e0 | 2025-03-19 | Boxed warning, Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| XeroBurn Burn Gel | LIDOCAINE HYDROCHLORIDE | Dynarex Corporation | 58985046-ca9c-12be-e053-2991aa0abe72 | 2025-03-13 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Novagenix Labs LLC | 7567ffb5-953a-4be9-9a02-c5a50dcd9306 | 2025-03-12 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | ARMAS PHARMACEUTICALS INC. | 2f6e0f3d-ceaf-a853-e063-6394a90a8efb | 2025-03-07 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lightning Products BURN RELIEF | LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | 555ac696-e761-4a5a-bed8-945dc64d5be5 | 2025-02-27 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | f1b26274-a55e-4321-b96c-ce0df830f205 | 2025-02-20 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | McKesson Corporation dba SKY Packaging | e1eabd6b-9bb8-646f-e053-2a95a90a7b83 | 2025-02-20 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.