LIDOCAINE

Product NDC
62332-424
11-digit product format
623320424
Labeler code
62332
Product ID
62332-424_cff70a7e-cf8a-4700-8c55-23dd4fe8ae71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA211469
Marketing category
ANDA
Marketing start
2018-11-30
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 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
A211469-001LIDOCAINELIDOCAINE5%OINTMENT / TOPICALAT2018-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211469-001AT

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211469-001LIDOCAINE5%OINTMENT / TOPICALBX2018-11-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211469-001LIDOCAINE5%OINTMENT / TOPICALBX2018-11-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A211469-001LIDOCAINE5%OINTMENT / TOPICALBX2018-11-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-233f01610625f2…
2019-09-15 20:21 UTC2019-09A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211469-001LIDOCAINE5%OINTMENT / TOPICALAT2018-11-23e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211469-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211469-001BX1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211469-001BX131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211469-001BX16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211469-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211469-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211469-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211469-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211469-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211469-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211469-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211469-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211469-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211469-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211469-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211469-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211469-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211469-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211469-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211469-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211469-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211469-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A211469-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211469-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211469-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211469-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A211469-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A211469-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211469-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211469-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211469-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211469-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211469-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211469-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211469-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211469-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211469-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211469-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211469-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211469-001AT1e64feba35796…

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
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
11a8b27a-1e25-46e5-bc23-ae5c894b4da4Available 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
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
62332-424-30LIDOCAINE30 g in 1 TUBEOINTMENT3012
62332-424-30LIDOCAINE1 in 1 CARTONOINTMENT112
62332-424-35LIDOCAINE1 in 1 CARTONOINTMENT112
62332-424-35LIDOCAINE35.44 g in 1 TUBEOINTMENT35.4412
62332-424-50LIDOCAINE50 g in 1 JAROINTMENT5012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-424-30GM - Gram62332-424366b8b04-e6b2-4212-98ac-f51cd0c4319512019-04-11
62332-424-35GM - Gram62332-424e48a845d-66af-4d63-9dcd-139a7604215112019-04-11
62332-424-50GM - Gram62332-4248ce71743-d92b-4696-80c0-93912cbb327e12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-424LIDOCAINE OINTMENT [ALEMBIC PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 5 package rows20231031_11a8b27a-1e25-46e5-bc23-ae5c894b4da4.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOCAINELIDOCAINEPreferred Pharmaceuticals, Inc.e7ed90d7-11c0-4781-a727-1fe3659a29482026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211469
application number: ANDA211469
LIDOCAINELIDOCAINEREMEDYREPACK INC.dfef4554-aeb4-4bdf-9557-648d3e84af3c2025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211469
application number: ANDA211469
LIDOCAINELIDOCAINEPHOENIX RX LLC3a63652c-92a1-612b-e063-6294a90a034a2025-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211469
application number: ANDA211469
LIDOCAINELIDOCAINEAlembic Pharmaceuticals Limited071b2cfd-07ad-46a3-8808-87080d545fd32025-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211469
application number: ANDA211469
LIDOCAINELIDOCAINEQuality Care Products, LLC38f31902-99fd-4a63-853e-b5f93dfc59802024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211469
application number: ANDA211469
LIDOCAINELIDOCAINEAdvanced Rx of Tennessee, LLC259f3f4b-50d0-066c-e063-6394a90a2a1e2024-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211469
application number: ANDA211469
LIDOCAINELIDOCAINEProficient Rx LPc98eeb63-c896-4417-b0ad-66c4a87efeee2024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211469
application number: ANDA211469
LIDOCAINELIDOCAINEAlembic Pharmaceuticals Inc.11a8b27a-1e25-46e5-bc23-ae5c894b4da42023-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211469
application number: ANDA211469
ndc (product): 62332-424

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN11a8b27a-1e25-46e5-bc23-ae5c894b4da412
1543069lidocaine 0.05 MG/MG Topical OintmentSCD11a8b27a-1e25-46e5-bc23-ae5c894b4da412
1543069lidocaine 5 % Topical OintmentSY11a8b27a-1e25-46e5-bc23-ae5c894b4da412
1543069lidocaine 5 % Topical OintmentPSNe7ed90d7-11c0-4781-a727-1fe3659a29485
1543069lidocaine 0.05 MG/MG Topical OintmentSCDe7ed90d7-11c0-4781-a727-1fe3659a29485
1543069lidocaine 5 % Topical OintmentSYe7ed90d7-11c0-4781-a727-1fe3659a29485
1543069lidocaine 5 % Topical OintmentPSN38f31902-99fd-4a63-853e-b5f93dfc59804
1543069lidocaine 0.05 MG/MG Topical OintmentSCD38f31902-99fd-4a63-853e-b5f93dfc59804
1543069lidocaine 5 % Topical OintmentSY38f31902-99fd-4a63-853e-b5f93dfc59804
1543069lidocaine 5 % Topical OintmentPSNc98eeb63-c896-4417-b0ad-66c4a87efeee3
1543069lidocaine 0.05 MG/MG Topical OintmentSCDc98eeb63-c896-4417-b0ad-66c4a87efeee3
1543069lidocaine 5 % Topical OintmentSYc98eeb63-c896-4417-b0ad-66c4a87efeee3
1543069lidocaine 5 % Topical OintmentPSNdfef4554-aeb4-4bdf-9557-648d3e84af3c2
1543069lidocaine 0.05 MG/MG Topical OintmentSCDdfef4554-aeb4-4bdf-9557-648d3e84af3c2
1543069lidocaine 5 % Topical OintmentSYdfef4554-aeb4-4bdf-9557-648d3e84af3c2
1543069lidocaine 5 % Topical OintmentPSN259f3f4b-50d0-066c-e063-6394a90a2a1e1
1543069lidocaine 5 % Topical OintmentPSN3a63652c-92a1-612b-e063-6294a90a034a1
1543069lidocaine 0.05 MG/MG Topical OintmentSCD3a63652c-92a1-612b-e063-6294a90a034a1
1543069lidocaine 0.05 MG/MG Topical OintmentSCD259f3f4b-50d0-066c-e063-6394a90a2a1e1
1543069lidocaine 5 % Topical OintmentSY3a63652c-92a1-612b-e063-6294a90a034a1
1543069lidocaine 5 % Topical OintmentSY259f3f4b-50d0-066c-e063-6394a90a2a1e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-424-30623320424301 TUBE in 1 CARTON (62332-424-30) / 30 g in 1 TUBE1 tube2018-11-300000-00-00NoNoCurrent
62332-424-35623320424351 TUBE in 1 CARTON (62332-424-35) / 35.44 g in 1 TUBE1 tube2018-11-300000-00-00NoNoCurrent
62332-424-506233204245050 g in 1 JAR (62332-424-50) 50 g2018-11-300000-00-00NoNoCurrent