ARTICAINE
- Product NDC
- 51004-1040
- 11-digit product format
- 510041040
- Labeler code
- 51004
- Product ID
- 51004-1040_a26a6d94-d595-4c89-94cb-651d024ebab4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Articaine Hydrochloride and Epinephrine
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBMUCOSAL
- Labeler
- Novocol Pharmaceutical of Canada, Inc.
- Application
- NDA020971
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2014-12-22
- Substance
- ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
- Active strength
- 40; .01 mg/mL; mg/mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], 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
- ARTICAINE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ARTICAINE HYDROCHLORIDE | 40 mg/mL |
| EPINEPHRINE BITARTRATE | .01 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QS9014Q792, 30Q7KI53AK |
| Rxcui | 1595035 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51004-1040-5 | ARTICAINE | 1.7 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 1.7 | | 1 |
| 51004-1040-5 | ARTICAINE | 50 in 1 CARTON | INJECTION, SOLUTION | 50 | | 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 |
|---|
| 51004-1040-5 | 51004104005 | 50 CARTRIDGE in 1 CARTON (51004-1040-5) / 1.7 mL in 1 CARTRIDGE | 50 cartridge | 2014-12-22 | No | No | Current |