septocaine and epinephrine

Generic: articaine hydrochloride and epinephrine bitartrate

Labeler: septodont inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name septocaine and epinephrine
Generic Name articaine hydrochloride and epinephrine bitartrate
Labeler septodont inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBMUCOSAL
Active Ingredients

articaine hydrochloride 40 mg/mL, epinephrine bitartrate .01 mg/mL

Manufacturer
Septodont Inc.

Identifiers & Regulatory

Product NDC 0362-9049
Product ID 0362-9049_85af79f0-c765-4758-8ae8-e68ebdb70dd8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020971
Listing Expiration 2026-12-31
Marketing Start 2011-01-12

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03629049
Hyphenated Format 0362-9049

Supplemental Identifiers

RxCUI
861588 1150829 1595029 1595035
UNII
30Q7KI53AK QS9014Q792

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name septocaine and epinephrine (source: ndc)
Generic Name articaine hydrochloride and epinephrine bitartrate (source: ndc)
Application Number NDA020971 (source: ndc)
Routes
SUBMUCOSAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
  • .01 mg/mL
source: ndc
Packaging
  • 50 CARTRIDGE in 1 CARTON (0362-9049-02) / 1.7 mL in 1 CARTRIDGE
source: ndc

Packages (1)

0362-9049-02 50 CARTRIDGE in 1 CARTON (0362-9049-02) / 1.7 mL in 1 CARTRIDGE

Ingredients (2)

articaine hydrochloride (40 mg/mL) epinephrine bitartrate (.01 mg/mL)

Linked Drug Pages (1)

Septocaine and Epinephrine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBMUCOSAL"], "spl_id": "85af79f0-c765-4758-8ae8-e68ebdb70dd8", "openfda": {"unii": ["30Q7KI53AK", "QS9014Q792"], "rxcui": ["861588", "1150829", "1595029", "1595035"], "spl_set_id": ["0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce03"], "manufacturer_name": ["Septodont Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 CARTRIDGE in 1 CARTON (0362-9049-02)  / 1.7 mL in 1 CARTRIDGE", "package_ndc": "0362-9049-02", "marketing_start_date": "20110112"}], "brand_name": "Septocaine and Epinephrine", "product_id": "0362-9049_85af79f0-c765-4758-8ae8-e68ebdb70dd8", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["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]"], "product_ndc": "0362-9049", "generic_name": "Articaine Hydrochloride and Epinephrine Bitartrate", "labeler_name": "Septodont Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Septocaine and Epinephrine", "active_ingredients": [{"name": "ARTICAINE HYDROCHLORIDE", "strength": "40 mg/mL"}, {"name": "EPINEPHRINE BITARTRATE", "strength": ".01 mg/mL"}], "application_number": "NDA020971", "marketing_category": "NDA", "marketing_start_date": "20110112", "listing_expiration_date": "20261231"}