Lidocaine
- Product NDC
- 0404-6512
- 11-digit product format
- 004046512
- Labeler code
- 0404
- Product ID
- 0404-6512_d52fdd12-b86a-45e5-9316-f0d683695e07
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lidocaine Hydrochloride and Epinephrine Bitartrate
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBMUCOSAL
- Labeler
- Henry Schein Inc.
- Application
- ANDA088390
- Marketing category
- ANDA
- Marketing start
- 2011-11-07
- Substance
- EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE
- Active strength
- .01; 20 mg/mL; mg/mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lidocaine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EPINEPHRINE BITARTRATE | .01 mg/mL |
| LIDOCAINE HYDROCHLORIDE | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 30Q7KI53AK, V13007Z41A |
| Rxcui | 1293648 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-6512-05 | Lidocaine | 1.7 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 1.7 | | 11 |
| 0404-6512-05 | Lidocaine | 50 in 1 CARTON | INJECTION, SOLUTION | 50 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Epinephrine Bitartrate | ACTIVE INGREDIENT | 30Q7KI53AK | LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HENRY SCEIN INC] | 1 | |
| Lidocaine Hydrochloride | ACTIVE INGREDIENT | V13007Z41A | LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HENRY SCEIN INC] | 1 | |
| Epinephrine | ACTIVE MOIETY | YKH834O4BH | LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HENRY SCEIN INC] | 1 | |
| Lidocaine | ACTIVE MOIETY | 98PI200987 | LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HENRY SCEIN INC] | 1 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HENRY SCEIN INC] | 1 | |
| Potassium Metabisulfite | INACTIVE INGREDIENT | 65OE787Q7W | LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HENRY SCEIN INC] | 1 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HENRY SCEIN INC] | 1 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HENRY SCEIN INC] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HENRY SCEIN INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-6512 | LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HENRY SCHEIN INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240209_f8d90500-f797-4238-8dd2-b59cbcd89d12.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 |
|---|
| 0404-6512-05 | 00404651205 | 50 CARTRIDGE in 1 CARTON (0404-6512-05) / 1.7 mL in 1 CARTRIDGE | 50 cartridge | 2011-11-07 | 0000-00-00 | No | No | Current |