FDA.reportPublic FDA data

Lidocaine and Prilocaine

Product NDC
68788-9774
11-digit product format
687889774
Labeler code
68788
Product ID
68788-9774_7c320df0-e425-423e-b4ec-90a8a8834cc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine and Prilocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA076290
Marketing category
ANDA
Marketing start
2012-07-26
Marketing end
0000-00-00
Substance
LIDOCAINE; PRILOCAINE
Active strength
25 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9774DDiscontinued by firm2026-07-31
excluded packagepackage68788-977468788-9774-3DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076290-001LIDOCAINE AND PRILOCAINELIDOCAINE; PRILOCAINE2.5%;2.5%CREAM / TOPICAL2003-09-25

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076290-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2003-09-25a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine and PrilocaineLIDOCAINE AND PRILOCAINENuCare Pharamceuticals,Inc.5900691d-8b50-7752-e053-2991aa0a5c5c2024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076290
application number: ANDA076290