Lidocaine Hydrochloride

Product NDC
70756-665
Requested package NDC
70756-665-05
11-digit product format
707560665
Labeler code
70756
Product ID
70756-665_b05d6a42-5934-45b8-a730-7d2a5aa06a9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Lifestar Pharma LLC
Application
ANDA217692
Marketing category
ANDA
Marketing start
2023-11-29
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
10 mg/mL
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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217692-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-06-16
A217692-002LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2023-06-16
A217692-003LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-11-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A217692-001AP
A217692-002AP
A217692-003AP

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 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217692-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-06-1684e616aacf4f…
2026-09-14 22:38:342026-08A217692-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2023-06-1684e616aacf4f…
2026-09-14 22:38:342026-08A217692-003LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-11-2984e616aacf4f…
2026-08-18 06:07:402026-07A217692-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-06-16caaa826d4ba7…
2026-08-18 06:07:402026-07A217692-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2023-06-16caaa826d4ba7…
2026-08-18 06:07:402026-07A217692-003LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-11-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217692-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-06-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217692-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2023-06-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217692-003LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-11-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217692-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-06-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217692-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2023-06-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217692-003LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-11-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A217692-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-06-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217692-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2023-06-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217692-003LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-11-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217692-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-06-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217692-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2023-06-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217692-003LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-11-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217692-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-06-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217692-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2023-06-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217692-003LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-11-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217692-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-06-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217692-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2023-06-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217692-003LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-11-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217692-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-06-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217692-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2023-06-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217692-003LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-11-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217692-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-06-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217692-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2023-06-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217692-003LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-11-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217692-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-06-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217692-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2023-06-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217692-003LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-11-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217692-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-06-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A217692-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2023-06-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A217692-003LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-11-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217692-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-06-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217692-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2023-06-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217692-003LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-11-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217692-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2023-06-16301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A217692-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A217692-002AP184e616aacf4f…
2026-09-14 22:38:342026-08A217692-003AP184e616aacf4f…
2026-08-18 06:07:402026-07A217692-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A217692-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A217692-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217692-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217692-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217692-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217692-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217692-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217692-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217692-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217692-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217692-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217692-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217692-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217692-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217692-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217692-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217692-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217692-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217692-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217692-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217692-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217692-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217692-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217692-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217692-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217692-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217692-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217692-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217692-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217692-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217692-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217692-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217692-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217692-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217692-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217692-001AP1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1737562Internal RxNorm lookup
1737566Internal RxNorm lookup
1737568Internal RxNorm lookup
1737757Internal RxNorm lookup
1737761Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8149138a-4106-4ae6-b7ad-f2559c7fa7e2Available 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
70756-665-05Lidocaine Hydrochloride30 mL in 1 VIALINJECTION, SOLUTION307
70756-665-05Lidocaine Hydrochloride5 in 1 CARTONINJECTION, SOLUTION57
70756-665-10Lidocaine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION107
70756-665-10Lidocaine Hydrochloride30 mL in 1 VIALINJECTION, SOLUTION307
70756-665-25Lidocaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION257
70756-665-25Lidocaine Hydrochloride30 mL in 1 VIALINJECTION, SOLUTION307
70756-665-88Lidocaine Hydrochloride1 in 1 CARTONINJECTION, SOLUTION17
70756-665-88Lidocaine Hydrochloride30 mL in 1 VIALINJECTION, SOLUTION307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-665LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [LIFESTAR PHARMA LLC]7Current NDC, 8 package rows20240815_8149138a-4106-4ae6-b7ad-f2559c7fa7e2.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
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution42df73b0-20ee-d1aa-e063-6294a90aa2752025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217692
application number: ANDA217692
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDELifestar Pharma LLC8149138a-4106-4ae6-b7ad-f2559c7fa7e22024-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217692
application number: ANDA217692
ndc (package): 70756-665-05
ndc (product): 70756-665
ndc11 (package): 70756066505
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDENorthStar RxLLCf065e6d2-b47e-433d-a1fb-f0449cd725f12024-07-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217692
application number: ANDA217692

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737568lidocaine HCl 1 % in 2 ML InjectionPSN8149138a-4106-4ae6-b7ad-f2559c7fa7e27
1737562lidocaine HCl 1 % in 30 ML InjectionPSN8149138a-4106-4ae6-b7ad-f2559c7fa7e27
1737566lidocaine HCl 1 % in 5 ML InjectionPSN8149138a-4106-4ae6-b7ad-f2559c7fa7e27
1737757lidocaine HCl 2 % in 2 ML InjectionPSN8149138a-4106-4ae6-b7ad-f2559c7fa7e27
1737761lidocaine HCl 2 % in 5 ML InjectionPSN8149138a-4106-4ae6-b7ad-f2559c7fa7e27
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCD8149138a-4106-4ae6-b7ad-f2559c7fa7e27
17377572 ML lidocaine hydrochloride 20 MG/ML InjectionSCD8149138a-4106-4ae6-b7ad-f2559c7fa7e27
173756230 ML lidocaine hydrochloride 10 MG/ML InjectionSCD8149138a-4106-4ae6-b7ad-f2559c7fa7e27
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCD8149138a-4106-4ae6-b7ad-f2559c7fa7e27
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCD8149138a-4106-4ae6-b7ad-f2559c7fa7e27
1737568lidocaine HCl 1 % per 2 ML InjectionSY8149138a-4106-4ae6-b7ad-f2559c7fa7e27
1737562lidocaine HCl 1 % per 30 ML InjectionSY8149138a-4106-4ae6-b7ad-f2559c7fa7e27
1737566lidocaine HCl 1 % per 5 ML InjectionSY8149138a-4106-4ae6-b7ad-f2559c7fa7e27
1737761lidocaine HCl 100 MG per 5 ML InjectionSY8149138a-4106-4ae6-b7ad-f2559c7fa7e27
1737757lidocaine HCl 2 % per 2 ML InjectionSY8149138a-4106-4ae6-b7ad-f2559c7fa7e27
1737761lidocaine HCl 2 % per 5 ML InjectionSY8149138a-4106-4ae6-b7ad-f2559c7fa7e27
1737568lidocaine HCl 20 MG per 2 ML InjectionSY8149138a-4106-4ae6-b7ad-f2559c7fa7e27
1737562lidocaine HCl 300 MG per 30 ML InjectionSY8149138a-4106-4ae6-b7ad-f2559c7fa7e27
1737757lidocaine HCl 40 MG per 2 ML InjectionSY8149138a-4106-4ae6-b7ad-f2559c7fa7e27
1737566lidocaine HCl 50 MG per 5 ML InjectionSY8149138a-4106-4ae6-b7ad-f2559c7fa7e27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-665-05707560665055 VIAL in 1 CARTON (70756-665-05) / 30 mL in 1 VIAL5 vial2023-11-29NoNoCurrent