lidocaine hydrochloride

Generic: lidocaine hydrochloride

Labeler: novitium pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lidocaine hydrochloride
Generic Name lidocaine hydrochloride
Labeler novitium pharma llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

lidocaine hydrochloride 40 mg/mL

Manufacturer
Novitium Pharma LLC

Identifiers & Regulatory

Product NDC 70954-518
Product ID 70954-518_ffb2d794-2c88-48a2-beff-d01b6fcea51f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216250
Listing Expiration 2026-12-31
Marketing Start 2022-03-23

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 70954518
Hyphenated Format 70954-518

Supplemental Identifiers

RxCUI
1010878
UPC
0370954518105
UNII
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 lidocaine hydrochloride (source: ndc)
Generic Name lidocaine hydrochloride (source: ndc)
Application Number ANDA216250 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70954-518-10) / 50 mL in 1 BOTTLE
source: ndc

Packages (1)

70954-518-10 1 BOTTLE in 1 CARTON (70954-518-10) / 50 mL in 1 BOTTLE

Ingredients (1)

lidocaine hydrochloride (40 mg/mL)

Linked Drug Pages (1)

Lidocaine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "ffb2d794-2c88-48a2-beff-d01b6fcea51f", "openfda": {"upc": ["0370954518105"], "unii": ["V13007Z41A"], "rxcui": ["1010878"], "spl_set_id": ["ffb2d794-2c88-48a2-beff-d01b6fcea51f"], "manufacturer_name": ["Novitium Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70954-518-10)  / 50 mL in 1 BOTTLE", "package_ndc": "70954-518-10", "marketing_start_date": "20220323"}], "brand_name": "Lidocaine Hydrochloride", "product_id": "70954-518_ffb2d794-2c88-48a2-beff-d01b6fcea51f", "dosage_form": "SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "70954-518", "generic_name": "Lidocaine Hydrochloride", "labeler_name": "Novitium Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lidocaine Hydrochloride", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE", "strength": "40 mg/mL"}], "application_number": "ANDA216250", "marketing_category": "ANDA", "marketing_start_date": "20220323", "listing_expiration_date": "20261231"}