Lidocaine hydrochloride
- Product NDC
- 68071-3486
- 11-digit product format
- 680713486
- Labeler code
- 68071
- Product ID
- 68071-3486_30b5b6e4-f174-1ec5-e063-6394a90a82af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lidocaine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL; TOPICAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA216780
- Marketing category
- ANDA
- Marketing start
- 2023-03-28
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lidocaine hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LIDOCAINE HYDROCHLORIDE | 20 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | V13007Z41A |
| Rxcui | 1010739 |
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 |
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| 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 |
|---|---|---|---|---|---|
| 68071-3486-0 | 2025-03-19 | C162847 | 48780-1 | 2cef2736-a2ba-d83d-e063-dadaa90ab31f | Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) |
| 68071-3486-0 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a2ba-d83d-e063-dadaa90ab31f | Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-3486-0 | Lidocaine hydrochloride | 100 mL in 1 BOTTLE | SOLUTION | 100 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-3486 | LIDOCAINE HYDROCHLORIDE SOLUTION [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, 1 package rows | 20250322_037764d3-da0e-5ebb-e063-6294a90ab6e0.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1010739 | lidocaine HCl 2 % Mucous Membrane Topical Solution | PSN | 037764d3-da0e-5ebb-e063-6294a90ab6e0 | 2 |
| 1010739 | lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical Solution | SCD | 037764d3-da0e-5ebb-e063-6294a90ab6e0 | 2 |
| 1010739 | lidocaine HCl 2 % Oral Topical Solution | SY | 037764d3-da0e-5ebb-e063-6294a90ab6e0 | 2 |
| 1010739 | lidocaine HCl 2 % Oromucosal Solution | SY | 037764d3-da0e-5ebb-e063-6294a90ab6e0 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-3486-0 | 68071348600 | 100 mL in 1 BOTTLE (68071-3486-0) | 100 ml | 2023-08-21 | No | No | Historical |