Lidovix L

Product NDC
72275-716
Requested package NDC
72275-716-77
11-digit product format
722750716
Labeler code
72275
Product ID
72275-716_a9ca7ea5-a57f-7bf9-e053-2995a90adce5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine 5%
Dosage form
KIT
Route
TOPICAL
Labeler
Primary Pharmaceuticals, Inc.
Application
ANDA205318
Marketing category
ANDA
Marketing start
2020-06-23
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72275-71672275-716-77IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A205318-001LIDOCAINELIDOCAINE5%OINTMENT / TOPICALAT2016-02-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205318-001AT

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 · 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 UTC2026-02A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-013f01610625f2…
2019-09-15 20:21 UTC2019-09A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-01cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205318-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205318-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205318-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205318-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205318-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205318-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205318-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A205318-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205318-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205318-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205318-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A205318-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205318-001AT1ea99ee380514…
2023-05-13 08:27 UTC2023-05A205318-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205318-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205318-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205318-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205318-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205318-001AT1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205318-001AT1a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72275-716-772023-01-30C16284748780-1f386c64a-1a22-0266-e053-dadaa90a7c1aLidovix L

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72275-716-77Lidovix L1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72275-716LIDOVIX L (LIDOCAINE 5%) KIT [PRIMARY PHARMACEUTICALS, INC.]2Legacy NDC, 1 package rows20200709_a8cbe325-5ed1-a2aa-e053-2a95a90abb3c.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDICAINEEncube Ethicals, Inc.e9f80c8a-05ba-47f8-aff1-e2583b2f8e572026-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205318
application number: ANDA205318
LidocaineLIDOCAINEAsclemed USA, Inc.c18f0c2b-cd05-4458-888f-47b4a11069372020-11-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205318
application number: ANDA205318
LidocaineLIDOCAINEProficient Rx LPcbf01b82-c43f-4bed-a1df-7569f4816c762019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205318
application number: ANDA205318

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSNa8cbe325-5ed1-a2aa-e053-2a95a90abb3c2
1543069lidocaine 0.05 MG/MG Topical OintmentSCDa8cbe325-5ed1-a2aa-e053-2a95a90abb3c2
1543069lidocaine 5 % Topical OintmentSYa8cbe325-5ed1-a2aa-e053-2a95a90abb3c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72275-716-77722750716771 KIT in 1 CARTON (72275-716-77) * 50 g in 1 JAR1 kit2020-06-230000-00-00NoNoCurrent