FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
55150-164
11-digit product format
551500164
Labeler code
55150
Product ID
55150-164_bab2ea79-0aed-4f48-8b4e-f864f8b82fb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Eugia US LLC
Application
ANDA203082
Marketing category
ANDA
Marketing start
2013-03-14
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
20 mg/mL
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 Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1737562, 1737566, 1737568, 1737757, 1737761

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
a831e694-3663-4a83-82be-6c309429f750Product name220200608
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-164-02Lidocaine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION1013
55150-164-02Lidocaine Hydrochloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION213
55150-164-09Lidocaine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION102
55150-164-09Lidocaine Hydrochloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-164MLK F1 KIT (MARCAINE, LIDOCAINE, KENALOG, POVIDONE IODINE) KIT [ASCLEMED USA, INC.]13Current NDC, Legacy NDC20241008_0cd42a2f-d202-447d-998e-8877ac3c0d38.zip
55150-164LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]11Current NDC, Legacy NDC, 2 package rows20250420_89701fac-7536-4f16-87fb-f4cc121e74ee.zip
55150-164MLK F3 KIT (MARCAINE, LIDOCAINE, KENALOG, POVIDONE IODINE) KIT [ASCLEMED USA, INC.]11Current NDC, Legacy NDC20241008_481aeef5-01cb-4567-a67f-896e6929b2ed.zip
55150-164MLK F4 KIT (TRIAMCINOLONE ACETONIDE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]11Current NDC, Legacy NDC20241008_829e3bd1-fb1c-4613-9db3-9a89ef8e2c0c.zip
55150-164LIDOLOG KIT (LIDOCAINE, KENALOG, POVIDONE IODINE) KIT [ASCLEMED USA, INC.]10Current NDC, Legacy NDC20241008_069e145d-7992-4f56-9fcb-20782ecc2d53.zip
55150-164LIDOLOG KIT (LIDOCAINE, KENALOG, POVIDONE IODINE) KIT [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, Legacy NDC20250102_fbbd12dd-c53f-2869-e053-6294a90a1a38.zip
55150-164LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]1Current NDC, Legacy NDC, 2 package rows20250202_9916b09d-a116-469d-92d5-60e50ea9782b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSN0cd42a2f-d202-447d-998e-8877ac3c0d3814
1737757lidocaine HCl 2 % in 2 ML InjectionPSN0cd42a2f-d202-447d-998e-8877ac3c0d3814
797730povidone-iodine 10 % Medicated PadPSN0cd42a2f-d202-447d-998e-8877ac3c0d3814
1792144triamcinolone acetonide 40 MG in 1 ML InjectionPSN0cd42a2f-d202-447d-998e-8877ac3c0d3814
17921441 ML triamcinolone acetonide 40 MG/ML InjectionSCD0cd42a2f-d202-447d-998e-8877ac3c0d3814
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD0cd42a2f-d202-447d-998e-8877ac3c0d3814
17377572 ML lidocaine hydrochloride 20 MG/ML InjectionSCD0cd42a2f-d202-447d-998e-8877ac3c0d3814
797730povidone-iodine 100 MG/ML Medicated PadSCD0cd42a2f-d202-447d-998e-8877ac3c0d3814
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSY0cd42a2f-d202-447d-998e-8877ac3c0d3814
1737757lidocaine HCl 2 % per 2 ML InjectionSY0cd42a2f-d202-447d-998e-8877ac3c0d3814
1737757lidocaine HCl 40 MG per 2 ML InjectionSY0cd42a2f-d202-447d-998e-8877ac3c0d3814
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY0cd42a2f-d202-447d-998e-8877ac3c0d3814
797730povidone-iodine 10 % Medicated PadSY0cd42a2f-d202-447d-998e-8877ac3c0d3814
797730povidone-iodine 10 % Medicated SwabstickSY0cd42a2f-d202-447d-998e-8877ac3c0d3814
1792144triamcinolone acetonide 40 MG per 1 ML InjectionSY0cd42a2f-d202-447d-998e-8877ac3c0d3814
1737568lidocaine HCl 1 % in 2 ML InjectionPSN89701fac-7536-4f16-87fb-f4cc121e74ee13
1737562lidocaine HCl 1 % in 30 ML InjectionPSN89701fac-7536-4f16-87fb-f4cc121e74ee13
1737566lidocaine HCl 1 % in 5 ML InjectionPSN89701fac-7536-4f16-87fb-f4cc121e74ee13
1737757lidocaine HCl 2 % in 2 ML InjectionPSN89701fac-7536-4f16-87fb-f4cc121e74ee13
1737761lidocaine HCl 2 % in 5 ML InjectionPSN89701fac-7536-4f16-87fb-f4cc121e74ee13
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCD89701fac-7536-4f16-87fb-f4cc121e74ee13
17377572 ML lidocaine hydrochloride 20 MG/ML InjectionSCD89701fac-7536-4f16-87fb-f4cc121e74ee13
173756230 ML lidocaine hydrochloride 10 MG/ML InjectionSCD89701fac-7536-4f16-87fb-f4cc121e74ee13
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCD89701fac-7536-4f16-87fb-f4cc121e74ee13
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCD89701fac-7536-4f16-87fb-f4cc121e74ee13
1737568lidocaine HCl 1 % per 2 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1737562lidocaine HCl 1 % per 30 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1737566lidocaine HCl 1 % per 5 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1737761lidocaine HCl 100 MG per 5 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1737757lidocaine HCl 2 % per 2 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1737761lidocaine HCl 2 % per 5 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1737568lidocaine HCl 20 MG per 2 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1737562lidocaine HCl 300 MG per 30 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1737757lidocaine HCl 40 MG per 2 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1737566lidocaine HCl 50 MG per 5 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSN829e3bd1-fb1c-4613-9db3-9a89ef8e2c0c12
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSN481aeef5-01cb-4567-a67f-896e6929b2ed12
1737757lidocaine HCl 2 % in 2 ML InjectionPSN481aeef5-01cb-4567-a67f-896e6929b2ed12
1737757lidocaine HCl 2 % in 2 ML InjectionPSN829e3bd1-fb1c-4613-9db3-9a89ef8e2c0c12
797730povidone-iodine 10 % Medicated PadPSN481aeef5-01cb-4567-a67f-896e6929b2ed12
797730povidone-iodine 10 % Medicated PadPSN829e3bd1-fb1c-4613-9db3-9a89ef8e2c0c12
1792144triamcinolone acetonide 40 MG in 1 ML InjectionPSN481aeef5-01cb-4567-a67f-896e6929b2ed12
1792144triamcinolone acetonide 40 MG in 1 ML InjectionPSN829e3bd1-fb1c-4613-9db3-9a89ef8e2c0c12
17921441 ML triamcinolone acetonide 40 MG/ML InjectionSCD481aeef5-01cb-4567-a67f-896e6929b2ed12
17921441 ML triamcinolone acetonide 40 MG/ML InjectionSCD829e3bd1-fb1c-4613-9db3-9a89ef8e2c0c12
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD829e3bd1-fb1c-4613-9db3-9a89ef8e2c0c12
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD481aeef5-01cb-4567-a67f-896e6929b2ed12
17377572 ML lidocaine hydrochloride 20 MG/ML InjectionSCD829e3bd1-fb1c-4613-9db3-9a89ef8e2c0c12
17377572 ML lidocaine hydrochloride 20 MG/ML InjectionSCD481aeef5-01cb-4567-a67f-896e6929b2ed12
797730povidone-iodine 100 MG/ML Medicated PadSCD829e3bd1-fb1c-4613-9db3-9a89ef8e2c0c12
797730povidone-iodine 100 MG/ML Medicated PadSCD481aeef5-01cb-4567-a67f-896e6929b2ed12
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSY481aeef5-01cb-4567-a67f-896e6929b2ed12
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSY829e3bd1-fb1c-4613-9db3-9a89ef8e2c0c12
1737757lidocaine HCl 2 % per 2 ML InjectionSY481aeef5-01cb-4567-a67f-896e6929b2ed12
1737757lidocaine HCl 2 % per 2 ML InjectionSY829e3bd1-fb1c-4613-9db3-9a89ef8e2c0c12
1737757lidocaine HCl 40 MG per 2 ML InjectionSY829e3bd1-fb1c-4613-9db3-9a89ef8e2c0c12
1737757lidocaine HCl 40 MG per 2 ML InjectionSY481aeef5-01cb-4567-a67f-896e6929b2ed12
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY829e3bd1-fb1c-4613-9db3-9a89ef8e2c0c12
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY481aeef5-01cb-4567-a67f-896e6929b2ed12
797730povidone-iodine 10 % Medicated PadSY829e3bd1-fb1c-4613-9db3-9a89ef8e2c0c12
797730povidone-iodine 10 % Medicated PadSY481aeef5-01cb-4567-a67f-896e6929b2ed12
797730povidone-iodine 10 % Medicated SwabstickSY481aeef5-01cb-4567-a67f-896e6929b2ed12
797730povidone-iodine 10 % Medicated SwabstickSY829e3bd1-fb1c-4613-9db3-9a89ef8e2c0c12
1792144triamcinolone acetonide 40 MG per 1 ML InjectionSY829e3bd1-fb1c-4613-9db3-9a89ef8e2c0c12
1792144triamcinolone acetonide 40 MG per 1 ML InjectionSY481aeef5-01cb-4567-a67f-896e6929b2ed12
1737757lidocaine HCl 2 % in 2 ML InjectionPSN069e145d-7992-4f56-9fcb-20782ecc2d5311
797730povidone-iodine 10 % Medicated PadPSN069e145d-7992-4f56-9fcb-20782ecc2d5311
1792144triamcinolone acetonide 40 MG in 1 ML InjectionPSN069e145d-7992-4f56-9fcb-20782ecc2d5311
17921441 ML triamcinolone acetonide 40 MG/ML InjectionSCD069e145d-7992-4f56-9fcb-20782ecc2d5311
17377572 ML lidocaine hydrochloride 20 MG/ML InjectionSCD069e145d-7992-4f56-9fcb-20782ecc2d5311
797730povidone-iodine 100 MG/ML Medicated PadSCD069e145d-7992-4f56-9fcb-20782ecc2d5311
1737757lidocaine HCl 2 % per 2 ML InjectionSY069e145d-7992-4f56-9fcb-20782ecc2d5311
1737757lidocaine HCl 40 MG per 2 ML InjectionSY069e145d-7992-4f56-9fcb-20782ecc2d5311
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY069e145d-7992-4f56-9fcb-20782ecc2d5311
797730povidone-iodine 10 % Medicated PadSY069e145d-7992-4f56-9fcb-20782ecc2d5311
797730povidone-iodine 10 % Medicated SwabstickSY069e145d-7992-4f56-9fcb-20782ecc2d5311
1792144triamcinolone acetonide 40 MG per 1 ML InjectionSY069e145d-7992-4f56-9fcb-20782ecc2d5311
1737568lidocaine HCl 1 % in 2 ML InjectionPSN9916b09d-a116-469d-92d5-60e50ea9782b2
1737562lidocaine HCl 1 % in 30 ML InjectionPSN9916b09d-a116-469d-92d5-60e50ea9782b2
1737566lidocaine HCl 1 % in 5 ML InjectionPSN9916b09d-a116-469d-92d5-60e50ea9782b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-164-025515001640210 VIAL, SINGLE-DOSE in 1 CARTON (55150-164-02) / 2 mL in 1 VIAL, SINGLE-DOSE2013-03-140000-00-00NoNoCurrent
55150-164-095515001640910 VIAL, SINGLE-DOSE in 1 CARTON (55150-164-09) / 2 mL in 1 VIAL, SINGLE-DOSE2013-03-14NoNoCurrent