FDA.reportPublic FDA data

Lidocaine 5%

Product NDC
82347-0505
11-digit product format
823470505
Labeler code
82347
Product ID
82347-0505_4dca819d-01d3-65d2-e063-6394a90ac4a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine 5%
Dosage form
PATCH
Route
TOPICAL
Labeler
YARAL Pharma Inc.
Application
ANDA209190
Marketing category
ANDA
Marketing start
2023-06-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine 5%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1745091

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
82347-0505-4Lidocaine 5%14 g in 1 POUCHPATCH144
82347-0505-5Lidocaine 5%30 in 1 PACKAGEPATCH304
82347-0505-4Relivyx Plus14 g in 1 POUCHPATCH14 g50 mg in 1g2
82347-0505-5Relivyx Plus30 in 1 PACKAGEPATCH50 mg in 1g2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82347-0505-4EA - Each82347-05056d8a9f65-f42d-416b-9f5f-a91337041aab12025-07-08
82347-0505-5EA - Each82347-0505a63abe4d-0546-4f4a-a9c8-e27da3aeca0912023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82347-0505LIDOCAINE 5% PATCH [YARAL PHARMA INC.]2Current NDC, 2 package rows20240718_fc495fc8-15d6-27c7-e053-6394a90ab30d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1745091lidocaine 5 % Medicated PatchPSN9b47102e-3b35-4aa7-a380-cd02ba9eac657
2678310Tridacaine 5 % Medicated PatchPSN9b47102e-3b35-4aa7-a380-cd02ba9eac657
2678310lidocaine 0.05 MG/MG Medicated Patch [Tridacaine]SBD9b47102e-3b35-4aa7-a380-cd02ba9eac657
1745091lidocaine 0.05 MG/MG Medicated PatchSCD9b47102e-3b35-4aa7-a380-cd02ba9eac657
1745091lidocaine 5 % Medicated PatchSY9b47102e-3b35-4aa7-a380-cd02ba9eac657
2678310Tridacaine 0.05 MG/MG Medicated PatchSY9b47102e-3b35-4aa7-a380-cd02ba9eac657
2678310Tridacaine 5 % Medicated PatchSY9b47102e-3b35-4aa7-a380-cd02ba9eac657
1745091lidocaine 5 % Medicated PatchPSN07a258e4-4858-43b3-e063-6394a90a50846
2642344Lidocan 5 % Medicated PatchPSN07a258e4-4858-43b3-e063-6394a90a50846
2642344lidocaine 0.05 MG/MG Medicated Patch [Lidocan]SBD07a258e4-4858-43b3-e063-6394a90a50846
1745091lidocaine 0.05 MG/MG Medicated PatchSCD07a258e4-4858-43b3-e063-6394a90a50846
1745091lidocaine 5 % Medicated PatchSY07a258e4-4858-43b3-e063-6394a90a50846
2642344Lidocan 0.05 MG/MG Medicated PatchSY07a258e4-4858-43b3-e063-6394a90a50846
2642344Lidocan 5 % Medicated PatchSY07a258e4-4858-43b3-e063-6394a90a50846
1745091lidocaine 5 % Medicated PatchPSN137f9cc1-68c0-edcc-e063-6394a90abf6a4
1745091lidocaine 5 % Medicated PatchPSNfc495fc8-15d6-27c7-e053-6394a90ab30d4
2642344Lidocan 5 % Medicated PatchPSN137f9cc1-68c0-edcc-e063-6394a90abf6a4
2642344lidocaine 0.05 MG/MG Medicated Patch [Lidocan]SBD137f9cc1-68c0-edcc-e063-6394a90abf6a4
1745091lidocaine 0.05 MG/MG Medicated PatchSCDfc495fc8-15d6-27c7-e053-6394a90ab30d4
1745091lidocaine 0.05 MG/MG Medicated PatchSCD137f9cc1-68c0-edcc-e063-6394a90abf6a4
1745091lidocaine 5 % Medicated PatchSY137f9cc1-68c0-edcc-e063-6394a90abf6a4
1745091lidocaine 5 % Medicated PatchSYfc495fc8-15d6-27c7-e053-6394a90ab30d4
2642344Lidocan 0.05 MG/MG Medicated PatchSY137f9cc1-68c0-edcc-e063-6394a90abf6a4
2642344Lidocan 5 % Medicated PatchSY137f9cc1-68c0-edcc-e063-6394a90abf6a4
1745091lidocaine 5 % Medicated PatchPSN1b6dc518-a15b-1cf9-e063-6294a90a63573
1745091lidocaine 5 % Medicated PatchPSN052fa8a3-0e3c-d9c2-e063-6394a90aadd73
1745091lidocaine 5 % Medicated PatchPSN1f33d51c-168c-55f2-e063-6394a90a89053
1745091lidocaine 5 % Medicated PatchPSN032b37a7-8a47-4809-a330-c76314225cbd3
2642344Lidocan 5 % Medicated PatchPSN1b6dc518-a15b-1cf9-e063-6294a90a63573
2642344Lidocan 5 % Medicated PatchPSN1f33d51c-168c-55f2-e063-6394a90a89053
2678310Tridacaine 5 % Medicated PatchPSN032b37a7-8a47-4809-a330-c76314225cbd3
2642344lidocaine 0.05 MG/MG Medicated Patch [Lidocan]SBD1b6dc518-a15b-1cf9-e063-6294a90a63573
2642344lidocaine 0.05 MG/MG Medicated Patch [Lidocan]SBD1f33d51c-168c-55f2-e063-6394a90a89053
2678310lidocaine 0.05 MG/MG Medicated Patch [Tridacaine]SBD032b37a7-8a47-4809-a330-c76314225cbd3
1745091lidocaine 0.05 MG/MG Medicated PatchSCD1b6dc518-a15b-1cf9-e063-6294a90a63573
1745091lidocaine 0.05 MG/MG Medicated PatchSCD052fa8a3-0e3c-d9c2-e063-6394a90aadd73
1745091lidocaine 0.05 MG/MG Medicated PatchSCD1f33d51c-168c-55f2-e063-6394a90a89053
1745091lidocaine 0.05 MG/MG Medicated PatchSCD032b37a7-8a47-4809-a330-c76314225cbd3
1745091lidocaine 5 % Medicated PatchSY1f33d51c-168c-55f2-e063-6394a90a89053
1745091lidocaine 5 % Medicated PatchSY032b37a7-8a47-4809-a330-c76314225cbd3
1745091lidocaine 5 % Medicated PatchSY052fa8a3-0e3c-d9c2-e063-6394a90aadd73
1745091lidocaine 5 % Medicated PatchSY1b6dc518-a15b-1cf9-e063-6294a90a63573
2642344Lidocan 0.05 MG/MG Medicated PatchSY1b6dc518-a15b-1cf9-e063-6294a90a63573
2642344Lidocan 0.05 MG/MG Medicated PatchSY1f33d51c-168c-55f2-e063-6394a90a89053
2642344Lidocan 5 % Medicated PatchSY1b6dc518-a15b-1cf9-e063-6294a90a63573
2642344Lidocan 5 % Medicated PatchSY1f33d51c-168c-55f2-e063-6394a90a89053
2678310Tridacaine 0.05 MG/MG Medicated PatchSY032b37a7-8a47-4809-a330-c76314225cbd3
2678310Tridacaine 5 % Medicated PatchSY032b37a7-8a47-4809-a330-c76314225cbd3
1745091lidocaine 5 % Medicated PatchPSN141fe2bd-b25a-eff8-e063-6294a90a2ae82
1745091lidocaine 5 % Medicated PatchPSN08aeb3f5-56ea-4fd7-b151-e6dc65f202da2
2642344Lidocan 5 % Medicated PatchPSN141fe2bd-b25a-eff8-e063-6294a90a2ae82
415976menthol 6 % Topical GelPSN08aeb3f5-56ea-4fd7-b151-e6dc65f202da2
2642344lidocaine 0.05 MG/MG Medicated Patch [Lidocan]SBD141fe2bd-b25a-eff8-e063-6294a90a2ae82
1745091lidocaine 0.05 MG/MG Medicated PatchSCD141fe2bd-b25a-eff8-e063-6294a90a2ae82
1745091lidocaine 0.05 MG/MG Medicated PatchSCD08aeb3f5-56ea-4fd7-b151-e6dc65f202da2
415976menthol 0.06 MG/MG Topical GelSCD08aeb3f5-56ea-4fd7-b151-e6dc65f202da2
1745091lidocaine 5 % Medicated PatchSY141fe2bd-b25a-eff8-e063-6294a90a2ae82
1745091lidocaine 5 % Medicated PatchSY08aeb3f5-56ea-4fd7-b151-e6dc65f202da2
2642344Lidocan 0.05 MG/MG Medicated PatchSY141fe2bd-b25a-eff8-e063-6294a90a2ae82
2642344Lidocan 5 % Medicated PatchSY141fe2bd-b25a-eff8-e063-6294a90a2ae82
415976menthol 6 % Topical GelSY08aeb3f5-56ea-4fd7-b151-e6dc65f202da2
1745091lidocaine 5 % Medicated PatchPSNfec1e759-60e4-47d4-bd54-947f18b103dd1
1745091lidocaine 5 % Medicated PatchPSN1ac8a196-010f-a986-e063-6294a90a948f1
1745091lidocaine 5 % Medicated PatchPSN526b8681-098f-3410-e063-6294a90a79fb1
1745091lidocaine 5 % Medicated PatchPSN50152ae0-aebd-4a08-a5c7-c8858e0259971
1745091lidocaine 5 % Medicated PatchPSN1dca5b81-72a9-4969-8552-d43091f72aab1
1745091lidocaine 0.05 MG/MG Medicated PatchSCD526b8681-098f-3410-e063-6294a90a79fb1
1745091lidocaine 0.05 MG/MG Medicated PatchSCD50152ae0-aebd-4a08-a5c7-c8858e0259971
1745091lidocaine 0.05 MG/MG Medicated PatchSCD1dca5b81-72a9-4969-8552-d43091f72aab1
1745091lidocaine 0.05 MG/MG Medicated PatchSCD1ac8a196-010f-a986-e063-6294a90a948f1
1745091lidocaine 0.05 MG/MG Medicated PatchSCDfec1e759-60e4-47d4-bd54-947f18b103dd1
1745091lidocaine 5 % Medicated PatchSY526b8681-098f-3410-e063-6294a90a79fb1
1745091lidocaine 5 % Medicated PatchSY50152ae0-aebd-4a08-a5c7-c8858e0259971
1745091lidocaine 5 % Medicated PatchSY1dca5b81-72a9-4969-8552-d43091f72aab1
1745091lidocaine 5 % Medicated PatchSY1ac8a196-010f-a986-e063-6294a90a948f1
1745091lidocaine 5 % Medicated PatchSYfec1e759-60e4-47d4-bd54-947f18b103dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82347-0505-48234705050414 g in 1 POUCH14 gHistorical
82347-0505-58234705050530 POUCH in 1 PACKAGE (82347-0505-5) / 14 g in 1 POUCH (82347-0505-4) 30 pouch2023-06-15NoNoHistorical