lidocaine hydrochloride

Generic: lidocaine hydrochloride anhydrous

Labeler: spectra medical devices, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lidocaine hydrochloride
Generic Name lidocaine hydrochloride anhydrous
Labeler spectra medical devices, llc
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL INFILTRATION INTRACAUDAL PERINEURAL
Active Ingredients

lidocaine hydrochloride anhydrous 10 mg/mL

Manufacturer
Spectra Medical Devices, LLC

Identifiers & Regulatory

Product NDC 65282-1605
Product ID 65282-1605_447bfde4-fff3-32a6-e063-6394a90a667e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208017
Listing Expiration 2026-12-31
Marketing Start 2018-04-18

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 652821605
Hyphenated Format 65282-1605

Supplemental Identifiers

RxCUI
1737566
UPC
0365282160515
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 lidocaine hydrochloride (source: ndc)
Generic Name lidocaine hydrochloride anhydrous (source: ndc)
Application Number ANDA208017 (source: ndc)
Routes
EPIDURAL INFILTRATION INTRACAUDAL PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 AMPULE in 1 CARTON (65282-1605-1) / 5 mL in 1 AMPULE
source: ndc

Packages (1)

65282-1605-1 25 AMPULE in 1 CARTON (65282-1605-1) / 5 mL in 1 AMPULE

Ingredients (1)

lidocaine hydrochloride anhydrous (10 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", "PERINEURAL"], "spl_id": "447bfde4-fff3-32a6-e063-6394a90a667e", "openfda": {"upc": ["0365282160515"], "unii": ["EC2CNF7XFP"], "rxcui": ["1737566"], "spl_set_id": ["e8ba012a-08a9-4f67-9f88-3284377e80be"], "manufacturer_name": ["Spectra Medical Devices, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 AMPULE in 1 CARTON (65282-1605-1)  / 5 mL in 1 AMPULE", "package_ndc": "65282-1605-1", "marketing_start_date": "20180418"}], "brand_name": "Lidocaine Hydrochloride", "product_id": "65282-1605_447bfde4-fff3-32a6-e063-6394a90a667e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "65282-1605", "generic_name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "labeler_name": "Spectra Medical Devices, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lidocaine Hydrochloride", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "strength": "10 mg/mL"}], "application_number": "ANDA208017", "marketing_category": "ANDA", "marketing_start_date": "20180418", "listing_expiration_date": "20261231"}