FDA.reportPublic FDA data

Lidocaine

Product NDC
55700-932
11-digit product format
557000932
Labeler code
55700
Product ID
55700-932_12220f2e-0380-4bbc-a287-c0627229cf34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
PATCH
Route
TOPICAL
Labeler
Quality Care; Products, LLC
Application
ANDA206463
Marketing category
ANDA
Marketing start
2022-02-01
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
700 mg/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-932DDiscontinued by firm2026-07-31
excluded packagepackage55700-93255700-932-30DDiscontinued 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
A206463-001LIDOCAINELIDOCAINE5%PATCH / TOPICALAB2020-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206463-001AB

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 22:54:322026-06A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206463-001AB1a50c72e98297…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINEASCLEMED USA INC.56a54ef4-7aa0-e181-e063-6394a90a3e0e2026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206463
application number: ANDA206463
LidocaineLIDOCAINEPreferred Pharmaceuticals Inc.ebc05cf9-e82b-4f7d-b5e7-3e62025ce68c2026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206463
application number: ANDA206463
Lidocaine PatchLIDOCAINE PATCHDirect_Rxeb503f1f-cd3a-ab76-e053-2995a90ab1c82026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206463
application number: ANDA206463
LidocaineLIDOCAINESportpharm LLC1112681c-8de7-472b-8db4-2702054b835b2026-02-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206463
application number: ANDA206463
LidocaineLIDOCAINEA-S Medication Solutions82bb7767-5407-4593-b6d4-90859890e3762026-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206463
application number: ANDA206463
LidocaineLIDOCAINEAvKARE0a4cc4f8-9c5d-d03f-e063-6394a90a1b2e2026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206463
application number: ANDA206463
LidocaineLIDOCAINEAdvanced Rx Pharmacy of Tennessee, LLCf94d388c-8471-885b-e053-6294a90ab67a2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206463
application number: ANDA206463
LidocaineLIDOCAINEAmneal Pharmaceuticals LLC1f46bdfd-3a38-49a3-a505-0192790486d02024-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206463
application number: ANDA206463
LidocaineLIDOCAINEBryant Ranch Prepackb4db5684-988f-44c4-a81e-5c04b8b0f6e72024-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206463
application number: ANDA206463
LidocaineLIDOCAINEBryant Ranch Prepack19c585f3-e635-44d4-8eb0-14529eb34dca2024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206463
application number: ANDA206463

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-932-30EA - Each55700-932053244be-e9c0-430a-81b1-2f1dd587795a12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-932LIDOCAINE PATCH [QUALITY CARE; PRODUCTS, LLC]4Legacy NDC20250110_00fb3aa3-04e2-42fd-8c23-ea63c237ba81.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-932-305570009323030 POUCH in 1 CARTON (55700-932-30) > 1 PATCH in 1 POUCH30 pouch2022-02-010000-00-00NoNoCurrent