Lidocaine Hydrochloride
- Product NDC
- 53002-3431
- 11-digit product format
- 530023431
- Labeler code
- 53002
- Product ID
- 53002-3431_4a6fe775-c243-49db-915c-9e937972ab01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lidocaine Hydrochloride
- Dosage form
- SOLUTION
- Route
- OROPHARYNGEAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA040708
- Marketing category
- ANDA
- Marketing start
- 2007-02-27
- Marketing end
- 0000-00-00
- Substance
- LIDOCAINE HYDROCHLORIDE ANHYDROUS
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53002-3431-1 | 2025-01-30 | C162847 | 48780-1 | f386c64a-4512-0266-e053-dadaa90a7c1a | LIDOCAINE HYDROCHLORIDE ORAL TOPICAL SOLUTION USP, 2% (Viscous) |
| 53002-3431-1 | 2023-06-08 | C162847 | 48780-1 | f386c64a-4512-0266-e053-dadaa90a7c1a | LIDOCAINE HYDROCHLORIDE ORAL TOPICAL SOLUTION USP, 2% (Viscous) |
| 53002-3431-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-4512-0266-e053-dadaa90a7c1a | LIDOCAINE HYDROCHLORIDE ORAL TOPICAL SOLUTION USP, 2% (Viscous) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-3431-1 | Lidocaine Hydrochloride | 100 mL in 1 BOTTLE, PLASTIC | SOLUTION | 100 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-3431 | LIDOCAINE HYDROCHLORIDE SOLUTION [RPK PHARMACEUTICALS, INC.] | 4 | Legacy NDC, 1 package rows | 20230609_7caad716-b66e-4fad-a8ee-87604d7709a7.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1010739 | lidocaine HCl 2 % Mucous Membrane Topical Solution | PSN | 7caad716-b66e-4fad-a8ee-87604d7709a7 | 4 |
| 1010739 | lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical Solution | SCD | 7caad716-b66e-4fad-a8ee-87604d7709a7 | 4 |
| 1010739 | lidocaine HCl 2 % Oral Topical Solution | SY | 7caad716-b66e-4fad-a8ee-87604d7709a7 | 4 |
| 1010739 | lidocaine HCl 2 % Oromucosal Solution | SY | 7caad716-b66e-4fad-a8ee-87604d7709a7 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-3431-1 | 53002343101 | 100 mL in 1 BOTTLE, PLASTIC (53002-3431-1) | 100 ml | 2021-01-01 | 0000-00-00 | No | No | Current |