Application 010418
- Type
- NDA
- Sponsor
- ASTRAZENECA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 005 | XYLOCAINE | LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 1% | No | No |
| 006 | XYLOCAINE W/ EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.005MG/ML;1% | No | No |
| 007 | XYLOCAINE | LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 2% | No | No |
| 008 | XYLOCAINE W/ EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.005MG/ML;2% | No | No |
| 009 | XYLOCAINE | LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 1.5% | No | No |
| 010 | XYLOCAINE W/ EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.005MG/ML;1.5% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N010418-005 | XYLOCAINE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | ||
| N010418-006 | XYLOCAINE W/ EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.005MG/ML;1% | INJECTABLE / INJECTION | Approved before 1982 | ||
| N010418-007 | XYLOCAINE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | ||
| N010418-008 | XYLOCAINE W/ EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.005MG/ML;2% | INJECTABLE / INJECTION | Approved before 1982 | ||
| N010418-009 | XYLOCAINE | LIDOCAINE HYDROCHLORIDE | 1.5% | INJECTABLE / INJECTION | Approved before 1982 | ||
| N010418-010 | XYLOCAINE W/ EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.005MG/ML;1.5% | INJECTABLE / INJECTION | Approved before 1982 |
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 | N010418-005 | XYLOCAINE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N010418-006 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1% | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N010418-007 | XYLOCAINE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N010418-008 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;2% | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N010418-009 | XYLOCAINE | 1.5% | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N010418-010 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1.5% | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N010418-005 | XYLOCAINE | 1% | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N010418-006 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1% | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N010418-007 | XYLOCAINE | 2% | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N010418-008 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;2% | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N010418-009 | XYLOCAINE | 1.5% | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N010418-010 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1.5% | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N010418-005 | XYLOCAINE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N010418-006 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1% | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N010418-007 | XYLOCAINE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N010418-008 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;2% | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N010418-009 | XYLOCAINE | 1.5% | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N010418-010 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1.5% | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010418-005 | XYLOCAINE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010418-006 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1% | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010418-007 | XYLOCAINE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010418-008 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;2% | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010418-009 | XYLOCAINE | 1.5% | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010418-010 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1.5% | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N010418-005 | XYLOCAINE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N010418-006 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1% | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N010418-007 | XYLOCAINE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N010418-008 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;2% | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N010418-009 | XYLOCAINE | 1.5% | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N010418-010 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1.5% | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010418-005 | XYLOCAINE | 1% | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010418-006 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1% | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010418-007 | XYLOCAINE | 2% | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010418-008 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;2% | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010418-009 | XYLOCAINE | 1.5% | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010418-010 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1.5% | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010418-005 | XYLOCAINE | 1% | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010418-006 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1% | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010418-007 | XYLOCAINE | 2% | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010418-008 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;2% | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… |
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 | Eugia US LLC | 5524cbfd-d6e6-42eb-aaa5-22495e0a86b6 | 2025-11-11 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| GuruNanda Pain Relief | LIDOCAINE HYDROCHLORIDE | GuruNanda, LLC. | 3ab6a133-8dca-e14e-e063-6394a90a85e7 | 2025-11-10 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Xylocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | Henry Schein, Inc. | 27c2e78d-d037-470d-b4fa-44c33d78f788 | 2025-11-07 | Warnings, Adverse reactions | Xylocaine |
| Xylocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | Henry Schein, Inc. | 6899113c-dee4-4227-9f68-475fcce6b91e | 2025-11-07 | Warnings, Adverse reactions | Xylocaine |
| Xylocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | Henry Schein, Inc. | cfcc8a07-b40c-476d-9a21-83487318ac85 | 2025-11-07 | Warnings, Adverse reactions | Xylocaine |
| Xylocaine | LIDOCAINE HYDROCHLORIDE | Henry Schein, Inc. | ffc87dfb-0e26-4b42-80fd-3fb7690119e3 | 2025-11-07 | Warnings, Adverse reactions | Xylocaine LIDOCAINE HYDROCHLORIDE |
| Xylocaine | LIDOCAINE HCL | Henry Schein, Inc. | a6019956-a6e0-4988-a870-6aee06c354c3 | 2025-11-07 | Warnings, Adverse reactions | Xylocaine |
| Lidocaine hydrochloride | LIDOCAINE HYDROCHLORIDE | A-S Medication Solutions | e67dee40-b243-4d6b-bc6b-e52c6cb798b8 | 2025-11-01 | Boxed warning, Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Henry Schein, Inc. | f73d4546-c9ac-4155-8492-552d6ce70c84 | 2025-10-31 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Henry Schein, Inc. | f0617ab8-555f-4cbe-9795-c922f5ef176e | 2025-10-31 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Henry Schein, Inc. | ddaee8bc-f55c-48b1-9b0e-ad1e2dd15a2c | 2025-10-31 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Marlex Pharmaceuticals, Inc. | e1badbba-59af-e451-e053-2a95a90a49f8 | 2025-10-30 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC. | 42531a38-7cff-de16-e063-6394a90a18d8 | 2025-10-29 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | A-S Medication Solutions | e6c83ad7-2821-432b-8610-0f54cfe610cb | 2025-10-21 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Ear Pain MD | LIDOCAINE HYDROCHLORIDE | Eosera Inc | 78c4418f-7f0f-447f-a94f-d4c89a081af1 | 2025-10-17 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Trilocaine | LIDOCAINE HYDROCHLORIDE | Trifluent Pharma LLC | c58257bf-f06b-48d1-92df-a680dbd5eea0 | 2025-10-15 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Trilogel | LIDOCAINE HYDROCHLORIDE | Trifluent Pharma LLC | 22af7d63-6a56-4a38-a95b-0f88410b23cb | 2025-10-14 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | The J. Molner Company LLC | 17880468-873f-6465-e063-6294a90a9c73 | 2025-10-06 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| equate Burn Relief | LIDOCAINE HYDROCHLORIDE | Walmart Inc | a90cbd92-80a5-4463-8152-b83165121a6f | 2025-10-02 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine hydrochloride | LIDOCAINE HYDROCHLORIDE | Xttrium Laboratories, Inc. | 40339593-1142-53ef-e063-6394a90afd4f | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.