FDA.reportPublic FDA data

lidocaine

Product NDC
16714-878
11-digit product format
167140878
Labeler code
16714
Product ID
16714-878_20cfc009-f49f-4467-801b-9dadfb1672dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Northstar Rx LLC
Application
ANDA206498
Marketing category
ANDA
Marketing start
2016-07-01
Substance
LIDOCAINE
Active strength
50 mg/g
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1543069

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
16714-878-01lidocaine35.44 g in 1 TUBEOINTMENT35.442
16714-878-01lidocaine1 in 1 CARTONOINTMENT12
16714-878-02lidocaine50 g in 1 JAROINTMENT502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-878-01GM - Gram16714-87817a77a6e-a4f8-4893-9b30-6e9d96297ba512019-05-02
16714-878-02GM - Gram16714-878062d1623-ac90-43f1-89be-9718116a889912019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-878LIDOCAINE OINTMENT [NORTHSTAR RX LLC]2Current NDC, Legacy NDC, 3 package rows20231012_cde68b0c-a1ee-421d-9ca8-bc571d2990ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN2cc3d25d-cefd-448d-beec-ac602c2110fd4
1543069lidocaine 5 % Topical OintmentPSN967b0c5d-679d-4b69-9d6a-bc322baf6e044
1543069lidocaine 0.05 MG/MG Topical OintmentSCD2cc3d25d-cefd-448d-beec-ac602c2110fd4
1543069lidocaine 0.05 MG/MG Topical OintmentSCD967b0c5d-679d-4b69-9d6a-bc322baf6e044
1543069lidocaine 5 % Topical OintmentSY2cc3d25d-cefd-448d-beec-ac602c2110fd4
1543069lidocaine 5 % Topical OintmentSY967b0c5d-679d-4b69-9d6a-bc322baf6e044
1543069lidocaine 5 % Topical OintmentPSNf18bae4a-11ac-7319-e053-2995a90ad1e83
1543069lidocaine 0.05 MG/MG Topical OintmentSCDf18bae4a-11ac-7319-e053-2995a90ad1e83
1543069lidocaine 5 % Topical OintmentSYf18bae4a-11ac-7319-e053-2995a90ad1e83
1543069lidocaine 5 % Topical OintmentPSNcde68b0c-a1ee-421d-9ca8-bc571d2990ab2
1543069lidocaine 0.05 MG/MG Topical OintmentSCDcde68b0c-a1ee-421d-9ca8-bc571d2990ab2
1543069lidocaine 5 % Topical OintmentSYcde68b0c-a1ee-421d-9ca8-bc571d2990ab2
1543069lidocaine 5 % Topical OintmentPSN8a85ea77-91ad-4222-9bfe-2ffaf73182e81
1543069lidocaine 0.05 MG/MG Topical OintmentSCD8a85ea77-91ad-4222-9bfe-2ffaf73182e81
1543069lidocaine 5 % Topical OintmentSY8a85ea77-91ad-4222-9bfe-2ffaf73182e81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-878-01167140878011 TUBE in 1 CARTON (16714-878-01) / 35.44 g in 1 TUBE1 tube2018-12-310000-00-00NoNoCurrent
16714-878-021671408780250 g in 1 JAR (16714-878-02) 50 g2018-12-310000-00-00NoNoCurrent