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 |
|---|---|---|---|---|---|---|---|---|---|
| 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… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010418-009 | XYLOCAINE | 1.5% | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010418-010 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1.5% | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010418-005 | XYLOCAINE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010418-006 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1% | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010418-007 | XYLOCAINE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010418-008 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;2% | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010418-009 | XYLOCAINE | 1.5% | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010418-010 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1.5% | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010418-005 | XYLOCAINE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010418-006 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1% | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010418-007 | XYLOCAINE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010418-008 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;2% | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010418-009 | XYLOCAINE | 1.5% | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010418-010 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1.5% | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010418-005 | XYLOCAINE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010418-006 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1% | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010418-007 | XYLOCAINE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010418-008 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;2% | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010418-009 | XYLOCAINE | 1.5% | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010418-010 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1.5% | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010418-005 | XYLOCAINE | 1% | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010418-006 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1% | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010418-007 | XYLOCAINE | 2% | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010418-008 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;2% | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010418-009 | XYLOCAINE | 1.5% | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010418-010 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1.5% | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N010418-005 | XYLOCAINE | 1% | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N010418-006 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1% | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N010418-007 | XYLOCAINE | 2% | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N010418-008 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;2% | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N010418-009 | XYLOCAINE | 1.5% | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N010418-010 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1.5% | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010418-005 | XYLOCAINE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010418-006 | XYLOCAINE W/ EPINEPHRINE | 0.005MG/ML;1% | INJECTABLE / INJECTION | Approved before 1982 | 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 | Henry Schein, Inc. | 23c8f711-e458-479a-9ab0-dcc851311e24 | 2026-09-10 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Viscous | LIDOCAINE HYDROCHLORIDE | REMEDYREPACK INC. | 6f8d20d2-6a91-4a5b-bfe8-f1baada38442 | 2026-09-03 | Boxed warning, Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| XYLOCAINE MPF | LIDOCAINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 1986c302-82a0-95a9-e063-6294a90a3339 | 2026-09-02 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 9920daef-b156-4a14-b641-f714191ffb5c | 2026-09-02 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | REMEDYREPACK INC. | f824b48c-7039-4ce1-b3df-b3597aba5beb | 2026-08-28 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Xylocaine | LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE | REMEDYREPACK INC. | 1414bcfc-1543-4ad4-83bd-4fc444a02e92 | 2026-08-27 | Warnings, Adverse reactions | Xylocaine |
| HUSTLE BUTTER NUMBING | LIDOCAINE HYDROCHLORIDE | H.B.D. D.I.S.T. INC. | d7dfb312-6c80-4a2d-b8b2-d9891cb0b74e | 2026-08-24 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Hospira, Inc. | ad1ef0a8-88db-4648-c098-d009eaeb4e5b | 2026-08-20 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Major Pharmaceuticals | 04e8dd94-93a8-427d-81ab-a95793d86c36 | 2026-08-18 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Xylocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Dentsply Pharmaceutical | 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1 | 2026-08-13 | Warnings, Adverse reactions | Xylocaine |
| CVS Pain Relief Roll-On Lidocaine with Lavender | LIDOCAINE HYDROCHLORIDE | CVS Pharmacy | 4aa53176-2103-b47b-e063-6394a90ac735 | 2026-08-12 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | Sentiss Pharmaceuticals LLC | 9b2d4f69-0c84-4956-b5c0-b4410acf62e0 | 2026-08-12 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Tattoo Wipe | LIDOCAINE HYDROCHLORIDE | MD Tattoo Company | 369c1d16-597c-e1dc-e063-6394a90a3104 | 2026-08-06 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Hospira, Inc. | 3b2dd84e-cee8-4e58-d494-395a65a353a0 | 2026-08-05 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Hospira, Inc. | 9c18eaf1-4a0b-4916-70b2-88a827494711 | 2026-08-05 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | YYBA CORP | 582a0001-da1e-909a-e063-6394a90a2b11 | 2026-08-03 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 46404c7b-2ea4-e47b-e063-6294a90a779f | 2026-08-03 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Xylocaine MPF | LIDOCAINE HYDROCHLORIDE | Sportpharm LLC | 50aa6133-0776-4714-9821-fe8581f635ca | 2026-07-28 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Aspercreme Lidocaine with Rosemary and Mint | LIDOCAINE HYDROCHLORIDE | Chattem, Inc. | 9d40bfea-85d0-4943-83e9-0c16e79a011c | 2026-07-28 | Warnings | LIDOCAINE HYDROCHLORIDE |
| AEROBURN | LIDOCAINE HYDROCHLORIDE | Aero Healthcare US LLC | f8fa72db-5f7a-4158-a2b3-f8bc0e12df9f | 2026-07-24 | Warnings | LIDOCAINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.