lidocaine hydrochloride

Generic: lidocaine hydrochloride

Labeler: avenacy, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lidocaine hydrochloride
Generic Name lidocaine hydrochloride
Labeler avenacy, llc
Dosage Form INJECTION, SOLUTION
Routes
INFILTRATION PERINEURAL
Active Ingredients

lidocaine hydrochloride 10 mg/mL

Manufacturer
Avenacy, LLC

Identifiers & Regulatory

Product NDC 83634-651
Product ID 83634-651_8fb1dd7b-f349-4a64-96c1-bd72bf748f3b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219535
Listing Expiration 2027-12-31
Marketing Start 2025-07-01

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 83634651
Hyphenated Format 83634-651

Supplemental Identifiers

RxCUI
1010033 1737562 1737566 1737568
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 ANDA219535 (source: ndc)
Routes
INFILTRATION PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 CARTON (83634-651-10) / 10 mL in 1 VIAL, MULTI-DOSE (83634-651-41)
  • 25 VIAL, MULTI-DOSE in 1 CARTON (83634-651-20) / 20 mL in 1 VIAL, MULTI-DOSE (83634-651-42)
  • 25 VIAL, MULTI-DOSE in 1 CARTON (83634-651-50) / 50 mL in 1 VIAL, MULTI-DOSE (83634-651-43)
source: ndc

Packages (3)

83634-651-10 25 VIAL, MULTI-DOSE in 1 CARTON (83634-651-10) / 10 mL in 1 VIAL, MULTI-DOSE (83634-651-41) 83634-651-20 25 VIAL, MULTI-DOSE in 1 CARTON (83634-651-20) / 20 mL in 1 VIAL, MULTI-DOSE (83634-651-42) 83634-651-50 25 VIAL, MULTI-DOSE in 1 CARTON (83634-651-50) / 50 mL in 1 VIAL, MULTI-DOSE (83634-651-43)

Ingredients (1)

lidocaine hydrochloride (10 mg/mL)

Linked Drug Pages (1)

lidocaine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INFILTRATION", "PERINEURAL"], "spl_id": "8fb1dd7b-f349-4a64-96c1-bd72bf748f3b", "openfda": {"unii": ["V13007Z41A"], "rxcui": ["1010033", "1737562", "1737566", "1737568"], "spl_set_id": ["46480253-29b9-4d7f-98ed-10377929026b"], "manufacturer_name": ["Avenacy, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 CARTON (83634-651-10)  / 10 mL in 1 VIAL, MULTI-DOSE (83634-651-41)", "package_ndc": "83634-651-10", "marketing_start_date": "20260215"}, {"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 CARTON (83634-651-20)  / 20 mL in 1 VIAL, MULTI-DOSE (83634-651-42)", "package_ndc": "83634-651-20", "marketing_start_date": "20260215"}, {"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 CARTON (83634-651-50)  / 50 mL in 1 VIAL, MULTI-DOSE (83634-651-43)", "package_ndc": "83634-651-50", "marketing_start_date": "20250701"}], "brand_name": "lidocaine hydrochloride", "product_id": "83634-651_8fb1dd7b-f349-4a64-96c1-bd72bf748f3b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "83634-651", "generic_name": "lidocaine hydrochloride", "labeler_name": "Avenacy, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lidocaine hydrochloride", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA219535", "marketing_category": "ANDA", "marketing_start_date": "20250701", "listing_expiration_date": "20271231"}