LIDOCAINE HYDROCHLORIDE
- Product NDC
- 51662-1454
- 11-digit product format
- 516621454
- Labeler code
- 51662
- Product ID
- 51662-1454_3310effb-5919-263a-e063-6394a90aba15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LIDOCAINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA083158
- Marketing category
- ANDA
- Marketing start
- 2005-12-01
- Substance
- LIDOCAINE HYDROCHLORIDE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A083158-001 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| A083158-002 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| A083158-003 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 20% | INJECTABLE / INJECTION | Approved before 1982 | ||
| A083158-005 | LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% | LIDOCAINE HYDROCHLORIDE | 200MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| A083158-006 | LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% | LIDOCAINE HYDROCHLORIDE | 400MG/100ML | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A083158-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A083158-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A083158-003 | LIDOCAINE HYDROCHLORIDE | 20% | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A083158-005 | LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% | 200MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A083158-006 | LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% | 400MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083158-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083158-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083158-003 | LIDOCAINE HYDROCHLORIDE | 20% | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083158-005 | LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% | 200MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083158-006 | LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% | 400MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A083158-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A083158-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A083158-003 | LIDOCAINE HYDROCHLORIDE | 20% | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A083158-005 | LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% | 200MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A083158-006 | LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% | 400MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083158-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083158-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083158-003 | LIDOCAINE HYDROCHLORIDE | 20% | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083158-005 | LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% | 200MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083158-006 | LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% | 400MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083158-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083158-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083158-003 | LIDOCAINE HYDROCHLORIDE | 20% | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083158-005 | LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% | 200MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083158-006 | LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% | 400MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083158-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083158-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083158-003 | LIDOCAINE HYDROCHLORIDE | 20% | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083158-005 | LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% | 200MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083158-006 | LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% | 400MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083158-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083158-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083158-003 | LIDOCAINE HYDROCHLORIDE | 20% | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083158-005 | LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% | 200MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083158-006 | LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% | 400MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083158-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083158-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083158-003 | LIDOCAINE HYDROCHLORIDE | 20% | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083158-005 | LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% | 200MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083158-006 | LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% | 400MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083158-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083158-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A083158-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A083158-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083158-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083158-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083158-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083158-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083158-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083158-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083158-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083158-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083158-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083158-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A083158-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A083158-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A083158-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A083158-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A083158-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A083158-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A083158-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A083158-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A083158-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A083158-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A083158-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A083158-002 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A083158-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A083158-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A083158-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A083158-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A083158-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A083158-002 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A083158-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A083158-002 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A083158-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A083158-002 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A083158-001 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A083158-002 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A083158-001 | AP | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A083158-002 | AP | 1 | 87673890dc5c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LIDOCAINE HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LIDOCAINE HYDROCHLORIDE | 20 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V13007Z41A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1012068 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2177b6fe-aa37-6f6b-e063-6294a90af09a | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51662-1454-1 | LIDOCAINE HYDROCHLORIDE | 5 mL in 1 SYRINGE | INJECTION, SOLUTION | 5 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51662-1454 | LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 2 | Current NDC, 1 package rows | 20250419_2177b6fe-aa37-6f6b-e063-6294a90af09a.zip |
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 | HF Acquisition Co LLC, DBA HealthFirst | 2177b6fe-aa37-6f6b-e063-6294a90af09a | 2026-07-10 | Warnings, Adverse reactions | 083158 ANDA083158 51662-1454 |
| 2% LIDOCAINE HCI | 2% LIDOCAINE HCI | HF Acquisition Co. LLC, DBA Health First | 74450548-62f4-b77f-e053-2991aa0ae5cf | 2024-03-08 | Warnings, Adverse reactions | 083158 ANDA083158 |
| LIDOCAINE HCI | LIDOCAINE HCI | HF Acquisition Co. LLC, DBA Health First | 7445cb32-208b-cbf7-e053-2a91aa0ad429 | 2024-01-29 | Warnings, Adverse reactions | 083158 ANDA083158 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1012068 | lidocaine HCl 2 % in 5 ML Prefilled Syringe | PSN | 2177b6fe-aa37-6f6b-e063-6294a90af09a | 2 |
| 1012068 | 5 ML lidocaine hydrochloride 20 MG/ML Prefilled Syringe | SCD | 2177b6fe-aa37-6f6b-e063-6294a90af09a | 2 |
| 1012068 | lidocaine HCl 100 MG per 5 ML Prefilled Syringe | SY | 2177b6fe-aa37-6f6b-e063-6294a90af09a | 2 |
| 1012068 | lidocaine HCl 2 % per 5 ML Prefilled Syringe | SY | 2177b6fe-aa37-6f6b-e063-6294a90af09a | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51662-1454-1 | 51662145401 | 5 mL in 1 SYRINGE (51662-1454-1) | 5 ml | 2005-12-01 | No | No | Historical |
| 51662-1454-3 | 51662145403 | 10 POUCH in 1 CASE (51662-1454-3) / 1 SYRINGE in 1 POUCH (51662-1454-2) / 5 mL in 1 SYRINGE (51662-1454-1) | 10 pouch | 2005-12-01 | 0 | Current |