Lidocaine

Product NDC
63629-5094
11-digit product format
636295094
Labeler code
63629
Product ID
63629-5094_c6770218-eb44-4dc9-8d8d-b206e584ed93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
PATCH
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA200675
Marketing category
ANDA
Marketing start
2013-09-15
Substance
LIDOCAINE
Active strength
50 mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200675-001LIDOCAINELIDOCAINE5%PATCH / TOPICALAB2012-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200675-001AB

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-233f01610625f2…
2019-09-15 20:21 UTC2019-09A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200675-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200675-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200675-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200675-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200675-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200675-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200675-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200675-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200675-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200675-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200675-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200675-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200675-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200675-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200675-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200675-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200675-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200675-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200675-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200675-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200675-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A200675-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200675-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200675-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200675-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A200675-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A200675-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200675-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200675-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200675-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200675-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200675-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200675-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200675-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A200675-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A200675-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200675-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200675-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200675-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A200675-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE50 mg/g

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
6d7fdc43-e493-449e-9af6-825e584b547aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-5094-1Lidocaine1 g in 1 POUCHPATCH11015
63629-5094-1Lidocaine30 in 1 CARTONPATCH301015
63629-5094-2Lidocaine3 in 1 CARTONPATCH31015
63629-5094-2Lidocaine1 g in 1 POUCHPATCH11015
63629-5094-3Lidocaine9 in 1 CARTONPATCH91015
63629-5094-3Lidocaine1 g in 1 POUCHPATCH11015
63629-5094-4Lidocaine10 in 1 CARTONPATCH101015
63629-5094-4Lidocaine1 g in 1 POUCHPATCH11015
63629-5094-5Lidocaine1 g in 1 POUCHPATCH11015
63629-5094-5Lidocaine14 in 1 CARTONPATCH141015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-5094-1EA - Each63629-50946f7d4696-73a8-44d7-aa19-27c312c5374212016-04-04
63629-5094-2EA - Each63629-50946deac20a-88fa-4b75-a793-671396df260412024-02-14
63629-5094-3EA - Each63629-5094d9214895-34c7-49ec-b3c5-3f7985b4c0a312024-02-14
63629-5094-5EA - Each63629-5094d841ec1d-3e20-4ec4-a8e6-24314791bbf412024-02-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
DIHYDROXYALUMINUM AMINOACETATEINACTIVE INGREDIENTDO250MG0W6LIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
GELATININACTIVE INGREDIENT2G86QN327LLIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
KAOLININACTIVE INGREDIENT24H4NWX5COLIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
SORBITOLINACTIVE INGREDIENT506T60A25RLIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HLIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
UREAINACTIVE INGREDIENT8W8T17847WLIDOCAINE PATCH [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5094LIDOCAINE PATCH [BRYANT RANCH PREPACK]1015Current NDC, Legacy NDC, 10 package rows20231117_6d7fdc43-e493-449e-9af6-825e584b547a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tridacaine IILIDOCAINETrifluent Pharma LLC1e940ba6-3916-4fc4-8886-481fc9685fc12026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675
LidocaineLIDOCAINEPureTek Corporation85e72943-6989-42f4-b519-a3ebbf4bc7772025-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675
LidocaineLIDOCAINECardinal Health 107, LLCeb808fdf-0420-45e9-ad17-8380d49d5c212025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675
LidocaineLIDOCAINEActavis Pharma, Inc.c18799cd-9e11-4196-9ab1-0a2a84585e562025-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675
LidocaineLIDOCAINEBryant Ranch Prepack4e856dd5-f2fa-4acb-a205-f87baf26b8cc2024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675
LidocaineLIDOCAINEBryant Ranch Prepack1d28d687-695e-4cd9-97e2-7d4fdab9772a2024-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675
LidocaineLIDOCAINEBryant Ranch Prepack6d7fdc43-e493-449e-9af6-825e584b547a2023-11-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675
ndc (product): 63629-5094
LidocaineLIDOCAINEAsclemed USA, Inc.80dadfb5-cbe6-475f-9980-a1b2559827532022-10-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675
LidocaineLIDOCAINEActavis Pharma, Inc.4d04052c-3e0a-469a-9265-99604f13e5072022-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675
LidocaineLIDOCAINEAVKAREec6a4720-9821-c0fc-e053-2995a90a05df2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1745091lidocaine 5 % Medicated PatchPSN6d7fdc43-e493-449e-9af6-825e584b547a1015
1745091lidocaine 0.05 MG/MG Medicated PatchSCD6d7fdc43-e493-449e-9af6-825e584b547a1015
1745091lidocaine 5 % Medicated PatchSY6d7fdc43-e493-449e-9af6-825e584b547a1015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5094-16362950940130 POUCH in 1 CARTON (63629-5094-1) / 1 g in 1 POUCH30 pouch2013-09-200000-00-00NoNoCurrent
63629-5094-2636295094023 POUCH in 1 CARTON (63629-5094-2) / 1 g in 1 POUCH3 pouch2013-09-200000-00-00NoNoCurrent
63629-5094-3636295094039 POUCH in 1 CARTON (63629-5094-3) / 1 g in 1 POUCH9 pouch2013-09-200000-00-00NoNoCurrent
63629-5094-46362950940410 POUCH in 1 CARTON (63629-5094-4) / 1 g in 1 POUCH10 pouch2013-09-200000-00-00NoNoCurrent
63629-5094-56362950940514 POUCH in 1 CARTON (63629-5094-5) / 1 g in 1 POUCH14 pouch2021-04-140000-00-00NoNoCurrent