Home NDC 68071-1625 Lidocaine and Prilocaine
Product NDC 68071-1625
11-digit product format 680711625
Labeler code 68071
Product ID 68071-1625_1d4d70bf-e74f-e3e8-e063-6294a90a5e08
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine and Prilocaine
Dosage form CREAM
Route TOPICAL
Labeler NuCare Pharamceuticals,Inc.
Application ANDA076290
Marketing category ANDA
Marketing start 2003-09-25
Substance LIDOCAINE; PRILOCAINE
Active strength 25; 25 mg/g; mg/g
Pharmacologic classes Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076290-001 LIDOCAINE AND PRILOCAINE LIDOCAINE; PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Lidocaine and Prilocaine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 25 mg/g PRILOCAINE 25 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98PI200987 Internal UNII lookup 046O35D44R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197877 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-1625-3 Lidocaine and Prilocaine 30 g in 1 BOX CREAM 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-1625 LIDOCAINE AND PRILOCAINE CREAM [NUCARE PHARAMCEUTICALS,INC.] 4 Current NDC, Legacy NDC, 1 package rows 20240716_5900691d-8b50-7752-e053-2991aa0a5c5c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68071-1625-3 68071162503 30 g in 1 BOX (68071-1625-3) 30 g 2017-09-12 0000-00-00 No No Current