Septocaine And Epinephrine Injection, Solution
NDC Package 0362-9049-02
Package Information
Septocaine And Epinephrine (articaine hydrochloride and epinephrine bitartrate) injection is septocaine®, an amide local anesthetic containing a vasoconstrictor, is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures. This formulation utilizes a injection, solution delivery system. Marketed by Septodont Inc., this product is identified by NDC 0362-9049 and is authorized under FDA application NDA020971.
Identification & Billing
- RxCUI: 1150829 - Septocaine 4 % / 1:200,000 in 1.7 mL Dental Cartridge
- RxCUI: 1150829 - 1.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML Cartridge [Septocaine]
- RxCUI: 1150829 - Septocaine 4 % / 1:200,000 (articaine HCl / epinephrine (as epinephrine bitartrate)) 1.7 ML Cartridge
- RxCUI: 1150829 - Septocaine 4 % with epinephrine 1:200,000 1.7 ML Cartridge
- RxCUI: 1595029 - articaine HCl 4 % / EPINEPHrine 1:200,000 in 1.7 mL Dental Cartridge
Clinical Specifications
- Adrenergic alpha-Agonists - [MoA] (Mechanism of Action)
- Adrenergic beta-Agonists - [MoA] (Mechanism of Action)
- Amide Local Anesthetic - [EPC] (Established Pharmacologic Class)
- Amides - [CS]
- Catecholamine - [EPC] (Established Pharmacologic Class)
- Catecholamines - [CS]
- Local Anesthesia - [PE] (Physiologic Effect)
- alpha-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
- beta-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 0362 - Septodont Inc.
- 0362-9049 - Septocaine And Epinephrine
- 0362-9049-02 - 50 CARTRIDGE in 1 CARTON / 1.7 mL in 1 CARTRIDGE
- 0362-9049 - Septocaine And Epinephrine
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0362-9049-02 identifies a specific commercial package of 50 cartridge in 1 carton / 1.7 ml in 1 cartridge of Septocaine And Epinephrine, a human prescription drug labeled by Septodont Inc.. This injection, solution is formulated for submucosal use and contains articaine hydrochloride; epinephrine bitartrate as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Septodont Inc. on January 12, 2011. The current certification is valid through December 31, 2026.
How is this Septodont Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00362904902. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.