FDA.reportPublic FDA data

Lidocaine Patch

Product NDC
72189-387
Requested package NDC
72189-387-30
11-digit product format
721890387
Labeler code
72189
Product ID
72189-387_4d3a5659-3b11-2c1c-e063-6294a90a6249
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Patch
Dosage form
PATCH
Route
TOPICAL
Labeler
Direct_Rx
Application
ANDA206463
Marketing category
ANDA
Marketing start
2022-10-18
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
2027-12-31
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-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
ndc (package): 72189-387-30
ndc (product): 72189-387
ndc11 (package): 72189038730
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

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Patch
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE700 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1745091Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
eb503f1f-cd3a-ab76-e053-2995a90ab1c8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-387-30Lidocaine Patch30 in 1 CARTONPATCH303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-387-30EA - Each72189-38731174180-41ab-42a5-85d3-92d0c978911212022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-387LIDOCAINE PATCH PATCH [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20250123_eb503f1f-cd3a-ab76-e053-2995a90ab1c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1745091lidocaine 5 % Medicated PatchPSNeb503f1f-cd3a-ab76-e053-2995a90ab1c83
1745091lidocaine 0.05 MG/MG Medicated PatchSCDeb503f1f-cd3a-ab76-e053-2995a90ab1c83
1745091lidocaine 5 % Medicated PatchSYeb503f1f-cd3a-ab76-e053-2995a90ab1c83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-387-307218903873030 PATCH in 1 CARTON (72189-387-30) 30 patch2022-10-180000-00-00NoNoCurrent