NDC 52120-200

Ultacan

Articaine Hydrochloride, Epinephrine Bitartrate

Ultacan 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: 52120-200_85dfc4ff-e676-4dac-9dd8-63c15af9842c
• NDC: 52120-200
• Product Type: Human Prescription Drug
• Proprietary Name: Ultacan
• 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: ANDA201751
• 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

Packaging

NDC 52120-200-10

100 CARTRIDGE in 1 BOX (52120-200-10) > 1.7 mL in 1 CARTRIDGE (52120-200-00)

• Marketing Start Date: 2017-07-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52120-200-00 [52120020000]

Ultacan INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA201751
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-07-11

NDC 52120-200-05 [52120020005]

Ultacan INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA201751
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-07-11
• Inactivation Date: 2020-01-31

NDC 52120-200-10 [52120020010]

Ultacan INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA201751
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-07-11
• Inactivation Date: 2020-01-31

NDC 52120-200-01 [52120020001]

Ultacan INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA201751
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-07-11
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ARTICAINE HYDROCHLORIDE	40 mg/mL

OpenFDA Data

• SPL SET ID: e005e3da-142d-4eba-a0c0-35e05b234130
• Manufacturer:
  • HANSAmed, Inc.
• UNII:
  • QS9014Q792
  • 30Q7KI53AK
• RxNorm Concept Unique ID - RxCUI:
  • 1928862
  • 1928858
  • 1928864
  • 1928853

Pharmacological Class

• 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 Crossover Matching brand name "Ultacan" or generic name "Articaine Hydrochloride, Epinephrine Bitartrate"

NDC	Brand Name	Generic Name
52120-200	Ultacan	articaine hydrochloride, epinephrine bitartrate
72304-015	Articaine Hydrochloride and Epinephrine	ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE
52120-100	Ultacan Forte	articaine hydrochloride, epinephrine bitartrate