lidocaine and prilocaine

Generic: lidocaine and prilocaine

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lidocaine and prilocaine
Generic Name lidocaine and prilocaine
Labeler alembic pharmaceuticals limited
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

lidocaine 25 mg/g, prilocaine 25 mg/g

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-582
Product ID 46708-582_59488591-1d11-453f-b2f2-b2a47825819a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213923
Listing Expiration 2026-12-31
Marketing Start 2025-04-03

Pharmacologic Class

Established (EPC)
amide local anesthetic [epc] antiarrhythmic [epc]
Chemical Structure
amides [cs]
Physiologic Effect
local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708582
Hyphenated Format 46708-582

Supplemental Identifiers

RxCUI
197877
UPC
0346708582043
UNII
98PI200987 046O35D44R
NUI
N0000175682 M0000897 N0000175426 N0000175976

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 and prilocaine (source: ndc)
Generic Name lidocaine and prilocaine (source: ndc)
Application Number ANDA213923 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (46708-582-04) / 5 g in 1 TUBE
  • 1 TUBE in 1 CARTON (46708-582-31) / 30 g in 1 TUBE
source: ndc

Packages (2)

46708-582-04 1 TUBE in 1 CARTON (46708-582-04) / 5 g in 1 TUBE 46708-582-31 1 TUBE in 1 CARTON (46708-582-31) / 30 g in 1 TUBE

Ingredients (2)

lidocaine (25 mg/g) prilocaine (25 mg/g)

Linked Drug Pages (1)

Lidocaine and Prilocaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "59488591-1d11-453f-b2f2-b2a47825819a", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "upc": ["0346708582043"], "unii": ["98PI200987", "046O35D44R"], "rxcui": ["197877"], "spl_set_id": ["54198bf6-c93c-42cd-9b2b-63918eb32880"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (46708-582-04)  / 5 g in 1 TUBE", "package_ndc": "46708-582-04", "marketing_start_date": "20250403"}, {"sample": false, "description": "1 TUBE in 1 CARTON (46708-582-31)  / 30 g in 1 TUBE", "package_ndc": "46708-582-31", "marketing_start_date": "20250403"}], "brand_name": "Lidocaine and Prilocaine", "product_id": "46708-582_59488591-1d11-453f-b2f2-b2a47825819a", "dosage_form": "CREAM", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amide Local Anesthetic [EPC]", "Amides [CS]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]", "Local Anesthesia [PE]"], "product_ndc": "46708-582", "generic_name": "Lidocaine and Prilocaine", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lidocaine and Prilocaine", "active_ingredients": [{"name": "LIDOCAINE", "strength": "25 mg/g"}, {"name": "PRILOCAINE", "strength": "25 mg/g"}], "application_number": "ANDA213923", "marketing_category": "ANDA", "marketing_start_date": "20250403", "listing_expiration_date": "20261231"}