lidocaine hydrochloride

Generic: lidocaine hydrochloride

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

Drug Facts

Product Profile

Brand Name lidocaine hydrochloride
Generic Name lidocaine hydrochloride
Labeler asclemed usa, inc.
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL INFILTRATION INTRACAUDAL
Active Ingredients

lidocaine hydrochloride 20 mg/mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-078
Product ID 76420-078_ead2d6e4-62f7-3b3c-e053-2a95a90a4ccd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084625
Listing Expiration 2026-12-31
Marketing Start 1975-06-16

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 76420078
Hyphenated Format 76420-078

Supplemental Identifiers

RxCUI
1737761
UNII
V13007Z41A

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 ANDA084625 (source: ndc)
Routes
EPIDURAL INFILTRATION INTRACAUDAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 5 mL in 1 VIAL, SINGLE-DOSE (76420-078-05)
source: ndc

Packages (1)

76420-078-05 5 mL in 1 VIAL, SINGLE-DOSE (76420-078-05)

Ingredients (1)

lidocaine hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Lidocaine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "INFILTRATION", "INTRACAUDAL"], "spl_id": "ead2d6e4-62f7-3b3c-e053-2a95a90a4ccd", "openfda": {"unii": ["V13007Z41A"], "rxcui": ["1737761"], "spl_set_id": ["fecd1797-7757-4da8-b3a1-24b258634243"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 VIAL, SINGLE-DOSE (76420-078-05)", "package_ndc": "76420-078-05", "marketing_start_date": "20200211"}], "brand_name": "Lidocaine Hydrochloride", "product_id": "76420-078_ead2d6e4-62f7-3b3c-e053-2a95a90a4ccd", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "76420-078", "generic_name": "Lidocaine Hydrochloride", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lidocaine Hydrochloride", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA084625", "marketing_category": "ANDA", "marketing_start_date": "19750616", "listing_expiration_date": "20261231"}