Lidocaine

Product NDC
72162-2085
Requested package NDC
72162-2085-3
11-digit product format
721622085
Labeler code
72162
Product ID
72162-2085_19c585f3-e635-44d4-8eb0-14529eb34dca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
PATCH
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA206463
Marketing category
ANDA
Marketing start
2020-08-25
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
2026-08-18 06:07:402026-07A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-244b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-24c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206463-001LIDOCAINE5%PATCH / TOPICALAB2020-08-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A206463-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206463-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206463-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206463-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206463-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206463-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206463-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206463-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206463-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206463-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206463-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206463-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206463-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206463-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206463-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206463-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206463-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206463-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A206463-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206463-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206463-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A206463-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206463-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206463-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206463-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206463-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206463-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206463-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206463-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206463-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206463-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206463-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206463-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206463-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206463-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206463-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206463-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206463-001AB1a50c72e98297…

Additional Listing Data#

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

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
19c585f3-e635-44d4-8eb0-14529eb34dcaAvailable 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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2085-3Lidocaine1 in 1 POUCHPATCH1101
72162-2085-3Lidocaine30 in 1 CARTONPATCH30101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2085-3EA - Each72162-208536350780-4259-4ebf-9cd2-f855316c87aa12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2085LIDOCAINE PATCH [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240418_19c585f3-e635-44d4-8eb0-14529eb34dca.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINEPHOENIX RX LLC57edfcb8-272c-8af4-e063-6294a90ae2e52026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206463
application number: ANDA206463
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
ndc (package): 72162-2085-3
ndc (product): 72162-2085
ndc11 (package): 72162208503

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1745091lidocaine 5 % Medicated PatchPSN19c585f3-e635-44d4-8eb0-14529eb34dca101
1745091lidocaine 0.05 MG/MG Medicated PatchSCD19c585f3-e635-44d4-8eb0-14529eb34dca101
1745091lidocaine 5 % Medicated PatchSY19c585f3-e635-44d4-8eb0-14529eb34dca101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2085-37216220850330 POUCH in 1 CARTON (72162-2085-3) / 1 PATCH in 1 POUCH30 pouch2020-08-25NoNoCurrent