Lidocaine
- Product NDC
- 50090-8166
- 11-digit product format
- 500908166
- Labeler code
- 50090
- Product ID
- 50090-8166_26a82044-8917-43fb-9162-3402ba693ef5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lidocaine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INFILTRATION; PERINEURAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA080407
- Marketing category
- ANDA
- Marketing start
- 1972-02-14
- Substance
- LIDOCAINE HYDROCHLORIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A080407-001 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | |
| A080407-002 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A080407-001 | AP |
| A080407-002 | AP |
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 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A080407-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | Approved before 1982 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A080407-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | Approved before 1982 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A080407-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A080407-002 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A080407-001 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A080407-002 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A080407-001 | AP | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A080407-002 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A080407-001 | AP | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A080407-002 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A080407-001 | AP | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A080407-002 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A080407-001 | AP | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A080407-002 | AP | 1 | c0c555d07b60… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A080407-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A080407-002 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A080407-001 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A080407-002 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A080407-001 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A080407-002 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A080407-001 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A080407-002 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A080407-001 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A080407-002 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A080407-001 | AP | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A080407-002 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A080407-001 | AP | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A080407-002 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A080407-001 | AP | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A080407-002 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A080407-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A080407-002 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A080407-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A080407-002 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A080407-001 | AP | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A080407-002 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A080407-001 | AP | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A080407-002 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A080407-001 | AP | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A080407-002 | AP | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A080407-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A080407-002 | AP | 1 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lidocaine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LIDOCAINE HYDROCHLORIDE | 10 mg/mL |
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 | LIDOCAINE HYDROCHLORIDE | Sportpharm LLC | 7adb9ab0-ef91-4c51-baa3-a0b7e12df077 | 2026-04-21 | Warnings, Adverse reactions | 080407 ANDA080407 |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | A-S Medication Solutions | e6c83ad7-2821-432b-8610-0f54cfe610cb | 2025-10-21 | Warnings, Adverse reactions | 080407 ANDA080407 |
| LIDOCAINE HCI | LIDOCAINE HCI | HF Acquisition Co LLC, DBA HealthFirst | 953471e2-9efb-adf0-e053-2a95a90afd95 | 2025-07-09 | Warnings, Adverse reactions | 080407 ANDA080407 |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 5523fdfe-69fd-49a5-b51f-73e2223d49a9 | 2025-05-01 | Warnings, Adverse reactions | 080407 ANDA080407 |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 86083fea-c064-4ef7-e053-2a91aa0ac17c | 2023-05-16 | Warnings, Adverse reactions | 080407 ANDA080407 |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 86093c75-6dde-bb16-e053-2991aa0ab6ef | 2023-05-16 | Warnings, Adverse reactions | 080407 ANDA080407 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 50090-8166-0 | 50090816600 | 1 VIAL, MULTI-DOSE in 1 PACKAGE (50090-8166-0) / 50 mL in 1 VIAL, MULTI-DOSE | 2026-10-22 | No | No | Current |