FDA.reportPublic FDA data

LIDOCAINE HYDROCHLORIDE

Product NDC
60432-465
Requested package NDC
60432-465-51
11-digit product format
604320465
Labeler code
60432
Product ID
60432-465_c39cdf5f-718a-4427-8bec-52ba31002e5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine hydrochloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Morton Grove Pharmaceuticals, Inc.
Application
ANDA087881
Marketing category
ANDA
Marketing start
1982-11-18
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
40 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60432-46560432-465-51DDiscontinued 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
A087881-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE4%SOLUTION / TOPICALAT1982-11-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A087881-001AT

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 22:54:322026-06A087881-001LIDOCAINE HYDROCHLORIDE4%SOLUTION / TOPICALAT1982-11-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A087881-001AT1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEBryant Ranch Prepack8f79b023-9bd1-4bd6-8fd0-f9efe88abec02026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087881
application number: ANDA087881
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEXttrium Laboratories, Inc.31a5a48e-27d7-90f3-e063-6294a90a2d9e2025-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087881
application number: ANDA087881

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60432-465-512025-12-10C16284748780-10191ceaa-63b4-198a-e063-dbdaa90aec3eLIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION, USP 4%
60432-465-512024-01-30C16284748780-10191ceaa-63b4-198a-e063-dbdaa90aec3eLIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION, USP 4%
60432-465-512023-11-03C16284748780-10191ceaa-63b4-198a-e063-dbdaa90aec3eLIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION, USP 4%
60432-465-512023-07-28C16284748780-10191ceaa-63b4-198a-e063-dbdaa90aec3eLIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION, USP 4%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-465-50ML - Milliliter60432-46523cc87b3-e479-48fe-86dd-a54a9f3066ac12012-07-24
60432-465-51ML - Milliliter60432-465b27f5470-4ce5-430c-9b2e-fccc598ec37312022-04-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
LidocaineACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3LIDOCAINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
WaterINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60432-465LIDOCAINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]11Legacy NDC20220311_521d6be9-72d9-4662-a62e-afc70197d620.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60432-465-51604320465511 BOTTLE, GLASS in 1 CARTON (60432-465-51) > 50 mL in 1 BOTTLE, GLASS (60432-465-50) 1982-11-180000-00-00NoNoCurrent