FDA.reportPublic FDA data

Lidocaine Hydrochloride and Epinephrine

Product NDC
0409-3183
11-digit product format
004093183
Labeler code
0409
Product ID
0409-3183_2bf70cff-3f29-4938-8728-b3bb31f04475
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE and EPINEPHRINE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Hospira, Inc.
Application
ANDA089651
Marketing category
ANDA
Marketing start
2005-07-06
Substance
LIDOCAINE HYDROCHLORIDE; EPINEPHRINE
Active strength
20; 5 mg/mL; ug/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
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 43.

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
A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A089651-001AP

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-2184e616aacf4f…
2026-08-18 06:07:402026-07A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-213f01610625f2…
2019-09-15 20:21 UTC2019-09A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089651-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAP1988-06-21f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-09-29 23:25 UTC2022-09A089651-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089651-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A089651-001AP1a50c72e98297…

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 and Epinephrine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE20 mg/mL
EPINEPHRINE5 ug/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
0409-3183-01Lidocaine Hydrochloride and Epinephrine5 in 1 CARTONINJECTION, SOLUTION534
0409-3183-11Lidocaine Hydrochloride and Epinephrine20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-3183-01ML - Milliliter0409-31837c6b0ea9-5463-49ef-9024-0b2b3664af0912012-07-24
0409-3183-11ML - Milliliter0409-3183499d24fa-bd59-48b1-a799-096f6391eff612020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EPINEPHRINEACTIVE INGREDIENTYKH834O4BHLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
EPINEPHRINEACTIVE MOIETYYKH834O4BHLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-3183LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.]32Current NDC, Legacy NDC, 2 package rows20250510_2f94f711-14c4-48ec-c5a3-c5ec4b8e8729.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010745lidocaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable SolutionPSN2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionPSN2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1867996lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1867998lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 in 5 ML InjectionPSN2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010759lidocaine HCl 2 % / EPINEPHrine 1:100,000 Injectable SolutionPSN2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010688lidocaine HCl 2 % / EPINEPHrine 1:200,000 in 20 ML InjectionPSN2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
101068820 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 20 MG/ML InjectionSCD2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
186799630 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 15 MG/ML InjectionSCD2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
18679985 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 15 MG/ML InjectionSCD2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010745epinephrine 0.005 MG/ML / lidocaine hydrochloride 5 MG/ML Injectable SolutionSCD2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010751epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010759epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Injectable SolutionSCD2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010751epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 1 % Injectable SolutionSY2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010759epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 2 % Injectable SolutionSY2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010745epinephrine (as epinephrine bitartrate) 1:200,000 / lidocaine hydrochloride 0.5 % Injectable SolutionSY2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010759epinephrine 1:100,000 / lidocaine hydrochloride 2 % Injectable SolutionSY2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010745lidocaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable SolutionSY2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionSY2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1867996lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 per 30 ML InjectionSY2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1867998lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 per 5 ML InjectionSY2f94f711-14c4-48ec-c5a3-c5ec4b8e872934
1010688lidocaine HCl 2 % / EPINEPHrine 1:200,000 per 20 ML InjectionSY2f94f711-14c4-48ec-c5a3-c5ec4b8e872934

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-3183-01004093183015 VIAL, SINGLE-DOSE in 1 CARTON (0409-3183-01) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-3183-11) 2005-07-060000-00-00NoNoCurrent
0409-3183-110040931831120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical