Lidocaine

Product NDC
87063-144
11-digit product format
870630144
Labeler code
87063
Product ID
87063-144_4cfaeecf-5d2a-d0a0-e063-6294a90a2448
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Asclemed USA, Inc.
Application
ANDA211697
Marketing category
ANDA
Marketing start
2021-03-01
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
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
A211697-001LIDOCAINELIDOCAINE5%OINTMENT / TOPICALAT2020-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211697-001AT

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
2026-02-19 14:30 UTC2026-02A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-164b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-16c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211697-001LIDOCAINE5%OINTMENT / TOPICALAT2020-03-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211697-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211697-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211697-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211697-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211697-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211697-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211697-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211697-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211697-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211697-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211697-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211697-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211697-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211697-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211697-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211697-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211697-001AT14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211697-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211697-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211697-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A211697-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211697-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211697-001AT1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211697-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211697-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211697-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211697-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211697-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211697-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211697-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211697-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211697-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211697-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211697-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211697-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211697-001AT1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211697-001AT1a50c72e98297…

Additional Listing Data#

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

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
1543069Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e0bfe16f-7a3f-48e0-a2e6-2ec68159a888Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87063-144-50Lidocaine1 in 1 CARTONOINTMENT11
87063-144-50Lidocaine50 g in 1 TUBEOINTMENT501

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINEREMEDYREPACK INC.9bf01533-ed83-4440-bdc4-4b45729bfc312026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211697
application number: ANDA211697
LidocaineLIDOCAINEMacleods Pharmaceuticals Limitedc788afd3-4554-40c4-8f26-2c31ab9b9b982026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211697
application number: ANDA211697
LidocaineLIDOCAINEAsclemed USA, Inc.e0bfe16f-7a3f-48e0-a2e6-2ec68159a8882026-03-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211697
application number: ANDA211697
ndc (product): 87063-144
LidocaineLIDOCAINEDirect_Rxfd8a640a-b5ca-f0a7-e053-6394a90ad6032025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211697
application number: ANDA211697

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSNe0bfe16f-7a3f-48e0-a2e6-2ec68159a8881
1543069lidocaine 0.05 MG/MG Topical OintmentSCDe0bfe16f-7a3f-48e0-a2e6-2ec68159a8881
1543069lidocaine 5 % Topical OintmentSYe0bfe16f-7a3f-48e0-a2e6-2ec68159a8881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87063-144-50870630144501 TUBE in 1 CARTON (87063-144-50) / 50 g in 1 TUBE1 tube2026-03-14NoNoCurrent