FDA.reportPublic FDA data

NA

Product NDC
68055-649
Requested package NDC
68055-649-10
11-digit product format
680550649
Labeler code
68055
Product ID
68055-649_e39eb612-8ff8-6a6c-e053-2a95a90a0252
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
RETROBULBAR
Labeler
SINTETICA SA
Application
ANDA214269
Marketing category
ANDA
Marketing start
2022-05-05
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
40 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68055-64968055-649-10IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A214269-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE4%INJECTABLE / INJECTIONAP2022-05-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214269-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A214269-001LIDOCAINE HYDROCHLORIDE4%INJECTABLE / INJECTIONAP2022-05-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214269-001AP1a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68055-649-01NA5 mL in 1 AMPULEINJECTION, SOLUTION52
68055-649-10NA10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68055-649NA (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [SINTETICA SA]2Legacy NDC, 2 package rows20220714_da0a1e50-ab34-4e5d-946e-6e0c6a7574ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010844lidocaine HCl 4 % in 5 ML InjectionPSNda0a1e50-ab34-4e5d-946e-6e0c6a7574ad2
10108445 ML lidocaine hydrochloride 40 MG/ML InjectionSCDda0a1e50-ab34-4e5d-946e-6e0c6a7574ad2
1010844lidocaine HCl 4 % per 5 ML InjectionSYda0a1e50-ab34-4e5d-946e-6e0c6a7574ad2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68055-649-106805506491010 AMPULE in 1 CARTON (68055-649-10) > 5 mL in 1 AMPULE (68055-649-01) 10 ampule2022-05-050000-00-00NoNoCurrent