Lidocaine Hydrochloride

Product NDC
31722-117
11-digit product format
317220117
Labeler code
31722
Product ID
31722-117_50208e47-95d1-c01a-e063-6294a90a7ecd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA214339
Marketing category
ANDA
Marketing start
2021-11-08
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
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
2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214339-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-08
A214339-002LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A214339-001AP
A214339-002AP

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 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-084b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214339-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2021-11-08782e0a99824c…
2021-12-28 21:50 UTC2021-12A214339-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2021-11-08782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A214339-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A214339-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214339-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214339-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214339-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214339-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214339-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214339-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214339-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214339-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214339-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214339-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214339-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214339-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214339-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214339-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214339-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214339-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214339-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214339-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214339-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214339-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214339-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214339-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214339-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214339-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214339-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214339-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214339-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214339-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214339-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214339-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214339-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214339-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214339-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A214339-002AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214339-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A214339-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214339-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A214339-002AP1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EC2CNF7XFPInternal 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
7f202319-effa-4dd8-b871-e720b75f4a83Available 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
31722-117-02Lidocaine Hydrochloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION27
31722-117-05Lidocaine Hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION57
31722-117-30Lidocaine Hydrochloride30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION307
31722-117-31Lidocaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION257
31722-117-32Lidocaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION257
31722-117-33Lidocaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION257
31722-117-34Lidocaine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION107
31722-117-35Lidocaine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-117-02ML - Milliliter31722-117b5484cd7-8f09-4035-bbf8-21335370a41f12024-11-05
31722-117-05ML - Milliliter31722-1170cae139b-754e-40f5-90fd-e2f6888f138a12024-11-05
31722-117-30ML - Milliliter31722-117a02c5206-adb1-4c57-aa0a-be7d3809e38c12024-10-04
31722-117-31ML - Milliliter31722-117c83539cd-c0ca-43e8-a463-95ecdbe4807f12024-11-05
31722-117-32ML - Milliliter31722-11797890141-8481-4331-a3d2-ad9c00546b7412024-11-05
31722-117-33ML - Milliliter31722-1177f47712f-c09e-4f25-bcce-6dfb546863dd12024-10-04
31722-117-34ML - Milliliter31722-11756003ba1-d7d9-4b50-85a7-b5e28c89529412024-11-05
31722-117-35ML - Milliliter31722-1171db62775-53df-485f-80e4-b9b94c5e34bc12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-117LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [CAMBER PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 8 package rows20250528_7f202319-effa-4dd8-b871-e720b75f4a83.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDECamber Pharmaceuticals, Inc.7f202319-effa-4dd8-b871-e720b75f4a832026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214339
application number: ANDA214339
ndc (product): 31722-117

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737568lidocaine HCl 1 % in 2 ML InjectionPSN7f202319-effa-4dd8-b871-e720b75f4a837
1737562lidocaine HCl 1 % in 30 ML InjectionPSN7f202319-effa-4dd8-b871-e720b75f4a837
1737566lidocaine HCl 1 % in 5 ML InjectionPSN7f202319-effa-4dd8-b871-e720b75f4a837
1737757lidocaine HCl 2 % in 2 ML InjectionPSN7f202319-effa-4dd8-b871-e720b75f4a837
1737761lidocaine HCl 2 % in 5 ML InjectionPSN7f202319-effa-4dd8-b871-e720b75f4a837
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCD7f202319-effa-4dd8-b871-e720b75f4a837
17377572 ML lidocaine hydrochloride 20 MG/ML InjectionSCD7f202319-effa-4dd8-b871-e720b75f4a837
173756230 ML lidocaine hydrochloride 10 MG/ML InjectionSCD7f202319-effa-4dd8-b871-e720b75f4a837
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCD7f202319-effa-4dd8-b871-e720b75f4a837
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCD7f202319-effa-4dd8-b871-e720b75f4a837
1737568lidocaine HCl 1 % per 2 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837
1737562lidocaine HCl 1 % per 30 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837
1737566lidocaine HCl 1 % per 5 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837
1737761lidocaine HCl 100 MG per 5 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837
1737757lidocaine HCl 2 % per 2 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837
1737761lidocaine HCl 2 % per 5 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837
1737568lidocaine HCl 20 MG per 2 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837
1737562lidocaine HCl 300 MG per 30 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837
1737757lidocaine HCl 40 MG per 2 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837
1737566lidocaine HCl 50 MG per 5 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-117-02317220117022 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
31722-117-05317220117055 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
31722-117-303172201173030 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
31722-117-313172201173125 VIAL, SINGLE-DOSE in 1 CARTON (31722-117-31) / 2 mL in 1 VIAL, SINGLE-DOSE (31722-117-02) 2021-11-080000-00-00NoNoCurrent
31722-117-323172201173225 VIAL, SINGLE-DOSE in 1 CARTON (31722-117-32) / 5 mL in 1 VIAL, SINGLE-DOSE (31722-117-05) 2021-11-080000-00-00NoNoCurrent
31722-117-333172201173325 VIAL, SINGLE-DOSE in 1 CARTON (31722-117-33) / 30 mL in 1 VIAL, SINGLE-DOSE (31722-117-30) 2023-12-05NoNoCurrent
31722-117-343172201173410 VIAL, SINGLE-DOSE in 1 CARTON (31722-117-34) / 2 mL in 1 VIAL, SINGLE-DOSE (31722-117-02) 2024-04-09NoNoCurrent
31722-117-353172201173510 VIAL, SINGLE-DOSE in 1 CARTON (31722-117-35) / 5 mL in 1 VIAL, SINGLE-DOSE (31722-117-05) 2024-04-09NoNoCurrent