Lidocaine
- Product NDC
- 63323-201
- 11-digit product format
- 633230201
- Labeler code
- 63323
- Product ID
- 63323-201_d19c26f4-1214-40f7-9680-43c885613306
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LIDOCAINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INFILTRATION; PERINEURAL
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA088586
- Marketing category
- ANDA
- Marketing start
- 2010-05-27
- 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
- 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 HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V13007Z41A |
| Rxcui | 1010033, 1737757 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-201-01 | Lidocaine | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 7 |
| 63323-201-02 | Lidocaine | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 7 |
| 63323-201-03 | Lidocaine | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 7 |
| 63323-201-10 | Lidocaine | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LIDOCAINE HYDROCHLORIDE | ACTIVE INGREDIENT | V13007Z41A | LIDOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| LIDOCAINE HYDROCHLORIDE ANHYDROUS | ACTIVE INGREDIENT | EC2CNF7XFP | LIDOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [US MEDSOURCE, LLC] | 1 | |
| LIDOCAINE | ACTIVE MOIETY | 98PI200987 | LIDOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [US MEDSOURCE, LLC] | 1 | |
| LIDOCAINE | ACTIVE MOIETY | 98PI200987 | LIDOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | LIDOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [US MEDSOURCE, LLC] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | LIDOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | LIDOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [US MEDSOURCE, LLC] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | LIDOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | LIDOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [US MEDSOURCE, LLC] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | LIDOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | LIDOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [US MEDSOURCE, LLC] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | LIDOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-201 | LIDOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 7 | Current NDC, Legacy NDC, 4 package rows | 20250409_cddb2b22-fce3-8967-6e54-dca3df5ac4b3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63323-201-01 | 63323020101 | 2 mL in 1 VIAL | 2 ml | | | | | Historical |
| 63323-201-02 | 63323020102 | 25 VIAL in 1 TRAY (63323-201-02) / 2 mL in 1 VIAL (63323-201-01) | 25 vial | 2010-05-27 | 0000-00-00 | No | No | Current |
| 63323-201-03 | 63323020103 | 10 mL in 1 VIAL | 10 ml | | | | | Historical |
| 63323-201-10 | 63323020110 | 25 VIAL in 1 TRAY (63323-201-10) / 10 mL in 1 VIAL (63323-201-03) | 25 vial | 2010-05-27 | 0000-00-00 | No | No | Current |