Flavalta
- Product NDC
- 0362-1200
- 11-digit product format
- 003621200
- Labeler code
- 0362
- Product ID
- 0362-1200_6ec4f11a-4a43-4a5b-8072-eefcc695b4be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lidocaine Hydrochloride and Epinephrine
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBMUCOSAL
- Labeler
- Septodont, Inc.
- Application
- NDA216564
- Marketing category
- NDA
- Marketing start
- 2026-03-19
- 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
- Flavalta
- 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, 2739501 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0362-1200-50 | Flavalta | 50 in 1 CARTON | INJECTION, SOLUTION | 50 | | 2 |
| 0362-1200-50 | Flavalta | 1.7 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 1.7 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0362-1200-50 | 00362120050 | 50 CARTRIDGE in 1 CARTON (0362-1200-50) / 1.7 mL in 1 CARTRIDGE | 50 cartridge | 2026-03-19 | No | No | Current |