Articadent
- Product NDC
- 66312-602
- 11-digit product format
- 663120602
- Labeler code
- 66312
- Product ID
- 66312-602_7b56ec0a-5b85-4069-a3b2-94654644aaa4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Articaine hydrochloride and Epinephrine Bitartrate
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBMUCOSAL
- Labeler
- Dentsply Pharmaceutical
- Application
- NDA020971
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2009-09-01
- Substance
- ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
- Active strength
- 40; .005 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Articadent
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ARTICAINE HYDROCHLORIDE | 40 mg/mL |
| EPINEPHRINE BITARTRATE | .005 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QS9014Q792, 30Q7KI53AK |
| Rxcui | 1011646, 1011648, 1595029, 1595035 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66312-602-16 | Articadent | 1.7 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 1.7 | | 9 |
| 66312-602-16 | Articadent | 50 in 1 CARTON | INJECTION, SOLUTION | 50 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Articaine hydrochloride | ACTIVE INGREDIENT | QS9014Q792 | ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 3 | |
| Epinephrine Bitartrate | ACTIVE INGREDIENT | 30Q7KI53AK | ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 3 | |
| Articaine | ACTIVE MOIETY | D3SQ406G9X | ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 3 | |
| Epinephrine | ACTIVE MOIETY | YKH834O4BH | ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 3 | |
| Sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 3 | |
| Sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 3 | |
| Sodium metabisulfite | INACTIVE INGREDIENT | 4VON5FNS3C | ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 3 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66312-602 | ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240302_9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1011648 | Articadent 4 % / 1:100,000 in 1.7 mL Dental Cartridge | PSN | 9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00 | 9 |
| 1011646 | Articadent 4 % / 1:200,000 in 1.7 mL Dental Cartridge | PSN | 9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00 | 9 |
| 1595035 | articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.7 mL Dental Cartridge | PSN | 9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00 | 9 |
| 1595029 | articaine HCl 4 % / EPINEPHrine 1:200,000 in 1.7 mL Dental Cartridge | PSN | 9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00 | 9 |
| 1011646 | 1.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML Cartridge [Articadent] | SBD | 9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00 | 9 |
| 1011648 | 1.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge [Articadent] | SBD | 9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00 | 9 |
| 1595029 | 1.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML Cartridge | SCD | 9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00 | 9 |
| 1595035 | 1.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge | SCD | 9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00 | 9 |
| 1011648 | Articadent (articaine HCl 4 % / epinephrine 1:100,000) 1.7 ML Cartridge | SY | 9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00 | 9 |
| 1011648 | Articadent 4 % / 1:100,000 in 1.7 mL Dental Cartridge | SY | 9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00 | 9 |
| 1011646 | Articadent 4 % / 1:200,000 (articaine HCl / epinephrine (as epinephrine bitartrate)) 1.7 ML Cartridge | SY | 9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00 | 9 |
| 1011646 | Articadent 4 % with epinephrine 1:200,000 1.7 ML Cartridge | SY | 9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00 | 9 |
| 1595035 | articaine HCl 4 % / epinephrine 1:100,000 (as epinephrine bitartrate 0.018 MG/ML) 1.7ML Dental Cartridge | SY | 9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00 | 9 |
| 1595035 | articaine HCl 4 % / epinephrine 1:100,000 1.7 ML Dental Cartridge | SY | 9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00 | 9 |
| 1595029 | articaine HCl 4 % / epinephrine 1:200,000 1.7 ML Cartridge | SY | 9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00 | 9 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 66312-602-16 | 66312060216 | 50 CARTRIDGE in 1 CARTON (66312-602-16) / 1.7 mL in 1 CARTRIDGE | 50 cartridge | 2009-09-01 | 0000-00-00 | No | No | Current |