lidocaine hydrochloride
- Product NDC
- 83634-653
- 11-digit product format
- 836340653
- Labeler code
- 83634
- Product ID
- 83634-653_8fb1dd7b-f349-4a64-96c1-bd72bf748f3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lidocaine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
- Labeler
- Avenacy, LLC
- Application
- ANDA219535
- Marketing category
- ANDA
- Marketing start
- 2025-12-31
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- lidocaine hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LIDOCAINE HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | V13007Z41A |
| Rxcui | 1010033, 1737562, 1737566, 1737568 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 070fbed5-7088-434a-a7ce-f2a64d8d40ac | Product name | 2 | 20260107 |
| bee66ce1-adb7-9d3b-67d9-582e4c54e80f | Product name | 5 | 20250819 |
| 860a93dc-4863-49cc-b284-6bbe8191bc48 | Product name | 4 | 20250214 |
| eaba870a-6a9d-442e-8643-87b3f558a451 | Product name | 1 | 20250117 |
| 9b4cf230-fd05-41d5-98c6-5db9ecb27b86 | Product name | 1 | 20230117 |
| 7d755fa1-1087-4dcd-98f0-6d4bba479a57 | Product name | 3 | 20210602 |
| aed701d5-9c75-dfaf-7154-cde46179faea | Product name | 9 | 20200313 |
| fa8b5901-e681-426f-82fe-54f6d81ec698 | Product name | 4 | 20180619 |
| 332d03e4-aa24-4b11-841a-02bf41081920 | Product name | 1 | 20171221 |
| c08ab52f-2fc8-4409-9d9f-ed8edc0bd070 | Product name | 1 | 20171221 |
| 68ed98f8-24c2-44a0-944a-6d36e82ce25a | Product name | 1 | 20141222 |
| 1cd42bc2-a430-c72b-636d-991b235fbf80 | Product name | 1 | 20140508 |
| 49fa150c-f0de-cce7-3d9c-993ed81c5698 | Product name | 1 | 20140508 |
| 4d7ae718-ed00-bae8-2abe-9eaec1eef7ff | Product name | 1 | 20140508 |
| 9137811f-f279-8640-5aeb-99fa2145d64d | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83634-653-02 | lidocaine hydrochloride | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | 4 | |
| 83634-653-05 | lidocaine hydrochloride | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | 4 | |
| 83634-653-30 | lidocaine hydrochloride | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | 4 | |
| 83634-653-41 | lidocaine hydrochloride | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | 4 | |
| 83634-653-42 | lidocaine hydrochloride | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | 4 | |
| 83634-653-43 | lidocaine hydrochloride | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 30 | 4 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1737568 | lidocaine HCl 1 % in 2 ML Injection | PSN | 46480253-29b9-4d7f-98ed-10377929026b | 4 |
| 1737562 | lidocaine HCl 1 % in 30 ML Injection | PSN | 46480253-29b9-4d7f-98ed-10377929026b | 4 |
| 1737566 | lidocaine HCl 1 % in 5 ML Injection | PSN | 46480253-29b9-4d7f-98ed-10377929026b | 4 |
| 1010033 | lidocaine HCl 1 % Injectable Solution | PSN | 46480253-29b9-4d7f-98ed-10377929026b | 4 |
| 1737568 | 2 ML lidocaine hydrochloride 10 MG/ML Injection | SCD | 46480253-29b9-4d7f-98ed-10377929026b | 4 |
| 1737562 | 30 ML lidocaine hydrochloride 10 MG/ML Injection | SCD | 46480253-29b9-4d7f-98ed-10377929026b | 4 |
| 1737566 | 5 ML lidocaine hydrochloride 10 MG/ML Injection | SCD | 46480253-29b9-4d7f-98ed-10377929026b | 4 |
| 1010033 | lidocaine hydrochloride 10 MG/ML Injectable Solution | SCD | 46480253-29b9-4d7f-98ed-10377929026b | 4 |
| 1737568 | lidocaine HCl 1 % per 2 ML Injection | SY | 46480253-29b9-4d7f-98ed-10377929026b | 4 |
| 1737562 | lidocaine HCl 1 % per 30 ML Injection | SY | 46480253-29b9-4d7f-98ed-10377929026b | 4 |
| 1737566 | lidocaine HCl 1 % per 5 ML Injection | SY | 46480253-29b9-4d7f-98ed-10377929026b | 4 |
| 1737568 | lidocaine HCl 20 MG per 2 ML Injection | SY | 46480253-29b9-4d7f-98ed-10377929026b | 4 |
| 1737562 | lidocaine HCl 300 MG per 30 ML Injection | SY | 46480253-29b9-4d7f-98ed-10377929026b | 4 |
| 1737566 | lidocaine HCl 50 MG per 5 ML Injection | SY | 46480253-29b9-4d7f-98ed-10377929026b | 4 |
| 1010033 | lidocaine hydrochloride 1 % Injectable Solution | SY | 46480253-29b9-4d7f-98ed-10377929026b | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83634-653-02 | 83634065302 | 25 VIAL, SINGLE-DOSE in 1 CARTON (83634-653-02) / 2 mL in 1 VIAL, SINGLE-DOSE (83634-653-41) | 2025-12-31 | No | No | Current | |
| 83634-653-05 | 83634065305 | 25 VIAL, SINGLE-DOSE in 1 CARTON (83634-653-05) / 5 mL in 1 VIAL, SINGLE-DOSE (83634-653-42) | 2025-12-31 | No | No | Current | |
| 83634-653-30 | 83634065330 | 25 VIAL, SINGLE-DOSE in 1 CARTON (83634-653-30) / 30 mL in 1 VIAL, SINGLE-DOSE (83634-653-43) | 2025-12-31 | No | No | Current | |
| 83634-653-41 | 83634065341 | 2 mL in 1 VIAL, SINGLE-DOSE | 2 ml | Historical | |||
| 83634-653-42 | 83634065342 | 5 mL in 1 VIAL, SINGLE-DOSE | 5 ml | Historical | |||
| 83634-653-43 | 83634065343 | 30 mL in 1 VIAL, SINGLE-DOSE | 30 ml | Historical |