lignospan standard

Generic: lidocaine hydrochloride and epinephrine

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

Drug Facts

Product Profile

Brand Name lignospan standard
Generic Name lidocaine hydrochloride and epinephrine
Labeler septodont, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBMUCOSAL
Active Ingredients

epinephrine bitartrate .01 mg/mL, lidocaine hydrochloride 20 mg/mL

Manufacturer
Septodont, Inc.

Identifiers & Regulatory

Product NDC 0362-1095
Product ID 0362-1095_5dd0f0a3-adbd-4a2f-90f7-a998735ef69a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088390
Listing Expiration 2026-12-31
Marketing Start 2017-11-28

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] adrenergic beta-agonists [moa] amide local anesthetic [epc] amides [cs] antiarrhythmic [epc] 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 03621095
Hyphenated Format 0362-1095

Supplemental Identifiers

RxCUI
1011809 1293648
UNII
30Q7KI53AK V13007Z41A

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 lignospan standard (source: ndc)
Generic Name lidocaine hydrochloride and epinephrine (source: ndc)
Application Number ANDA088390 (source: ndc)
Routes
SUBMUCOSAL
source: ndc

Resolved Composition

Strengths
  • .01 mg/mL
  • 20 mg/mL
source: ndc
Packaging
  • 5 BLISTER PACK in 1 CARTON (0362-1095-60) / 10 CARTRIDGE in 1 BLISTER PACK / 1.7 mL in 1 CARTRIDGE
source: ndc

Packages (1)

0362-1095-60 5 BLISTER PACK in 1 CARTON (0362-1095-60) / 10 CARTRIDGE in 1 BLISTER PACK / 1.7 mL in 1 CARTRIDGE

Ingredients (2)

epinephrine bitartrate (.01 mg/mL) lidocaine hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Lignospan Standard ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBMUCOSAL"], "spl_id": "5dd0f0a3-adbd-4a2f-90f7-a998735ef69a", "openfda": {"unii": ["30Q7KI53AK", "V13007Z41A"], "rxcui": ["1011809", "1293648"], "spl_set_id": ["f902d2b4-28fc-41b1-a9f7-0d1a63c598aa"], "manufacturer_name": ["Septodont, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (0362-1095-60)  / 10 CARTRIDGE in 1 BLISTER PACK / 1.7 mL in 1 CARTRIDGE", "package_ndc": "0362-1095-60", "marketing_start_date": "20171128"}], "brand_name": "Lignospan Standard", "product_id": "0362-1095_5dd0f0a3-adbd-4a2f-90f7-a998735ef69a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Agonists [MoA]", "Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Catecholamine [EPC]", "Catecholamines [CS]", "Local Anesthesia [PE]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Agonist [EPC]"], "product_ndc": "0362-1095", "generic_name": "Lidocaine Hydrochloride and Epinephrine", "labeler_name": "Septodont, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lignospan Standard", "active_ingredients": [{"name": "EPINEPHRINE BITARTRATE", "strength": ".01 mg/mL"}, {"name": "LIDOCAINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA088390", "marketing_category": "ANDA", "marketing_start_date": "20171128", "listing_expiration_date": "20261231"}