Ultacan Forte is a Submucosal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hansamed, Inc.. The primary component is Articaine Hydrochloride; Epinephrine Bitartrate.
| Product ID | 52120-100_85dfc4ff-e676-4dac-9dd8-63c15af9842c |
| NDC | 52120-100 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Ultacan Forte |
| Generic Name | Articaine Hydrochloride, Epinephrine Bitartrate |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBMUCOSAL |
| Marketing Start Date | 2017-07-11 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA201750 |
| Labeler Name | HANSAmed, Inc. |
| Substance Name | ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
| Active Ingredient Strength | 40 mg/mL; mg/mL |
| Pharm Classes | Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
| Marketing Start Date | 2017-07-11 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA201750 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-07-11 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA201750 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-07-11 |
| Marketing Category | ANDA |
| Application Number | ANDA201750 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-07-11 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA201750 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-07-11 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| ARTICAINE HYDROCHLORIDE | 40 mg/mL |
| SPL SET ID: | e005e3da-142d-4eba-a0c0-35e05b234130 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 52120-100 | Ultacan Forte | articaine hydrochloride, epinephrine bitartrate |
| 72304-015 | Articaine Hydrochloride and Epinephrine | ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE |
| 52120-200 | Ultacan | articaine hydrochloride, epinephrine bitartrate |