akten

Generic: lidocaine hydrochloride anhydrous

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

Drug Facts

Product Profile

Brand Name akten
Generic Name lidocaine hydrochloride anhydrous
Labeler thea pharma inc.
Dosage Form GEL
Routes
OPHTHALMIC
Active Ingredients

lidocaine hydrochloride anhydrous 35 mg/mL

Manufacturer
Thea Pharma Inc.

Identifiers & Regulatory

Product NDC 82584-792
Product ID 82584-792_4574f976-7ac4-ae37-e063-6294a90ab69d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022221
Listing Expiration 2026-12-31
Marketing Start 2022-12-01

Pharmacologic Class

Classes
amide local anesthetic [epc] amides [cs] antiarrhythmic [epc] local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82584792
Hyphenated Format 82584-792

Supplemental Identifiers

RxCUI
1009462 1011703
UPC
0382584792015
UNII
EC2CNF7XFP

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 akten (source: ndc)
Generic Name lidocaine hydrochloride anhydrous (source: ndc)
Application Number NDA022221 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 35 mg/mL
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (82584-792-01) / 1 mL in 1 TUBE
  • 25 TUBE in 1 CARTON (82584-792-25) / 1 mL in 1 TUBE
source: ndc

Packages (2)

82584-792-01 1 TUBE in 1 CARTON (82584-792-01) / 1 mL in 1 TUBE 82584-792-25 25 TUBE in 1 CARTON (82584-792-25) / 1 mL in 1 TUBE

Ingredients (1)

lidocaine hydrochloride anhydrous (35 mg/mL)

Linked Drug Pages (1)

AKTEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "4574f976-7ac4-ae37-e063-6294a90ab69d", "openfda": {"upc": ["0382584792015"], "unii": ["EC2CNF7XFP"], "rxcui": ["1009462", "1011703"], "spl_set_id": ["70ff9fb7-d323-4fe6-b1b1-6033e05f0749"], "manufacturer_name": ["Thea Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (82584-792-01)  / 1 mL in 1 TUBE", "package_ndc": "82584-792-01", "marketing_start_date": "20221201"}, {"sample": false, "description": "25 TUBE in 1 CARTON (82584-792-25)  / 1 mL in 1 TUBE", "package_ndc": "82584-792-25", "marketing_start_date": "20221201"}], "brand_name": "AKTEN", "product_id": "82584-792_4574f976-7ac4-ae37-e063-6294a90ab69d", "dosage_form": "GEL", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "82584-792", "generic_name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "labeler_name": "Thea Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AKTEN", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "strength": "35 mg/mL"}], "application_number": "NDA022221", "marketing_category": "NDA", "marketing_start_date": "20221201", "listing_expiration_date": "20261231"}