Lidocaine Hydrochloride and Dextrose

Product NDC
84549-594
11-digit product format
845490594
Labeler code
84549
Product ID
84549-594_48c0ee87-f723-1a71-e063-6394a90a72d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
ProPharma Distribution
Application
NDA019830
Marketing category
NDA
Marketing start
1992-04-08
Substance
DEXTROSE MONOHYDRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
5; .4 g/100mL; g/100mL
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 1.

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
N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTIONAP1992-04-08
N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE400MG/100MLINJECTABLE / INJECTIONAP1992-04-08
N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE800MG/100MLINJECTABLE / INJECTIONAP1992-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019830-002AP
N019830-003AP
N019830-004AP

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-088072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N019830-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019830-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019830-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019830-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019830-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019830-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019830-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019830-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019830-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019830-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019830-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019830-004AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019830-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019830-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019830-004AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019830-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019830-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019830-004AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019830-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019830-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019830-004AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019830-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019830-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019830-004AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019830-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019830-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019830-004AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019830-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019830-003AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019830-004AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019830-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019830-003AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019830-004AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019830-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019830-003AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019830-004AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019830-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019830-003AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019830-004AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019830-002AP18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS5 g/100mL
DEXTROSE MONOHYDRATE.4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EC2CNF7XFPInternal UNII lookup
LX22YL083GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1737742Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
48c0ee87-f722-1a71-e063-6394a90a72d1Available 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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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
84549-594-20Lidocaine Hydrochloride and Dextrose250 mL in 1 CONTAINERINJECTION, SOLUTION2501

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 Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS AND DEXTROSE MONOHYDRATEProPharma Distribution48c0ee87-f722-1a71-e063-6394a90a72d12026-01-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 019830
application number: NDA019830
ndc (product): 84549-594
Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS AND DEXTROSE MONOHYDRATEB. Braun Medical Inc.7dff29d9-522d-40eb-a9d9-42377912d6402026-01-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 019830
application number: NDA019830
LIDOCAINE HCI AND DEXTROSELIDOCAINE HCI AND DEXTROSEHF Acquisition Co LLC, DBA HealthFirstc75311e3-ca6e-40de-e053-2a95a90a1bda2021-07-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 019830
application number: NDA019830

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737742lidocaine HCl 0.4 % in 250 ML InjectionPSN48c0ee87-f722-1a71-e063-6394a90a72d11
1737742250 ML lidocaine hydrochloride 4 MG/ML InjectionSCD48c0ee87-f722-1a71-e063-6394a90a72d11
1737742lidocaine HCl 0.4 % per 250 ML InjectionSY48c0ee87-f722-1a71-e063-6394a90a72d11
1737742lidocaine HCl 1 GM per 250 ML InjectionSY48c0ee87-f722-1a71-e063-6394a90a72d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84549-594-2084549059420250 mL in 1 CONTAINER (84549-594-20) 250 ml2026-01-19NoNoCurrent