ARTICAINE
- Product NDC
- 50227-1050
- 11-digit product format
- 502271050
- Labeler code
- 50227
- Product ID
- 50227-1050_268a30b5-0677-4e63-90e6-1316928180b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Articaine Hydrochloride and Epinephrine
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBMUCOSAL
- Labeler
- Patterson Dental
- Application
- NDA020971
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2014-12-22
- 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
- ARTICAINE
- 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 | 1595029 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50227-1050-5 | ARTICAINE | 50 in 1 CARTON | INJECTION, SOLUTION | 50 | | 6 |
| 50227-1050-5 | ARTICAINE | 1.7 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 1.7 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Articaine hydrochloride | ACTIVE INGREDIENT | QS9014Q792 | ARTICAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [PATTERSON DENTAL] | 1 | |
| Epinephrine Bitartrate | ACTIVE INGREDIENT | 30Q7KI53AK | ARTICAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [PATTERSON DENTAL] | 1 | |
| Articaine | ACTIVE MOIETY | D3SQ406G9X | ARTICAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [PATTERSON DENTAL] | 1 | |
| Epinephrine | ACTIVE MOIETY | YKH834O4BH | ARTICAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [PATTERSON DENTAL] | 1 | |
| Sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | ARTICAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [PATTERSON DENTAL] | 1 | |
| Sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | ARTICAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [PATTERSON DENTAL] | 1 | |
| Sodium metabisulfite | INACTIVE INGREDIENT | 4VON5FNS3C | ARTICAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [PATTERSON DENTAL] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | ARTICAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [PATTERSON DENTAL] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50227-1050 | ARTICAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [PATTERSON DENTAL] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240308_2b5a7ee3-71ee-4c41-ad9f-852f170470b3.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 |
|---|
| 50227-1050-5 | 50227105005 | 50 CARTRIDGE in 1 CARTON (50227-1050-5) / 1.7 mL in 1 CARTRIDGE | 50 cartridge | 2014-12-22 | 0000-00-00 | No | No | Current |