lidocaine hydrochloride

Generic: lidocaine hydrochloride

Labeler: anthea pharma private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lidocaine hydrochloride
Generic Name lidocaine hydrochloride
Labeler anthea pharma private limited
Dosage Form INJECTION, SOLUTION
Routes
INFILTRATION PERINEURAL
Active Ingredients

lidocaine hydrochloride 10 mg/mL

Manufacturer
Anthea Pharma Private Limited

Identifiers & Regulatory

Product NDC 83854-009
Product ID 83854-009_4a5fc1fb-f45b-4ffd-e063-6294a90a1ba5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219535
Listing Expiration 2027-12-31
Marketing Start 2025-04-09

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 83854009
Hyphenated Format 83854-009

Supplemental Identifiers

RxCUI
1010033 1010671 1737562 1737566 1737568 1737757 1737761
UPC
0383854012017
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 in 1 TRAY (83854-009-25) / 50 mL in 1 VIAL (83854-009-01)
  • 25 VIAL in 1 CARTON (83854-009-26) / 10 mL in 1 VIAL (83854-009-02)
  • 25 VIAL in 1 CARTON (83854-009-27) / 20 mL in 1 VIAL (83854-009-03)
source: ndc

Packages (3)

83854-009-25 25 VIAL in 1 TRAY (83854-009-25) / 50 mL in 1 VIAL (83854-009-01) 83854-009-26 25 VIAL in 1 CARTON (83854-009-26) / 10 mL in 1 VIAL (83854-009-02) 83854-009-27 25 VIAL in 1 CARTON (83854-009-27) / 20 mL in 1 VIAL (83854-009-03)

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": "4a5fc1fb-f45b-4ffd-e063-6294a90a1ba5", "openfda": {"upc": ["0383854012017"], "unii": ["V13007Z41A"], "rxcui": ["1010033", "1010671", "1737562", "1737566", "1737568", "1737757", "1737761"], "spl_set_id": ["240c4744-e58c-4c08-93ad-8d6418c4f8a9"], "manufacturer_name": ["Anthea Pharma Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 TRAY (83854-009-25)  / 50 mL in 1 VIAL (83854-009-01)", "package_ndc": "83854-009-25", "marketing_start_date": "20250409"}, {"sample": false, "description": "25 VIAL in 1 CARTON (83854-009-26)  / 10 mL in 1 VIAL (83854-009-02)", "package_ndc": "83854-009-26", "marketing_start_date": "20251229"}, {"sample": false, "description": "25 VIAL in 1 CARTON (83854-009-27)  / 20 mL in 1 VIAL (83854-009-03)", "package_ndc": "83854-009-27", "marketing_start_date": "20251229"}], "brand_name": "Lidocaine Hydrochloride", "product_id": "83854-009_4a5fc1fb-f45b-4ffd-e063-6294a90a1ba5", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "83854-009", "generic_name": "Lidocaine Hydrochloride", "labeler_name": "Anthea Pharma Private Limited", "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": "20250409", "listing_expiration_date": "20271231"}