Lidocaine
- Product NDC
- 80425-0538
- 11-digit product format
- 804250538
- Labeler code
- 80425
- Product ID
- 80425-0538_3a9aed71-0064-6931-e063-6294a90a0957
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lidocaine
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA086724
- Marketing category
- ANDA
- Marketing start
- 2025-07-23
- Substance
- LIDOCAINE
- Active strength
- 50 mg/g
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LIDOCAINE | 50 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 98PI200987 |
| Rxcui | 1543069 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0538-1 | Lidocaine | 50 g in 1 JAR | OINTMENT | 50 | | 1 |
| 80425-0538-1 | Lidocaine | 1 in 1 CARTON | OINTMENT | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0538-1 | 80425053801 | 1 JAR in 1 CARTON (80425-0538-1) / 50 g in 1 JAR | 1 jar | 2025-07-23 | No | No | Historical |