FDA.reportPublic FDA data

LIDOCAINE

Product NDC
71205-429
11-digit product format
712050429
Labeler code
71205
Product ID
71205-429_d4215b37-bf64-43d3-ac9d-88c1323fd98b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA211469
Marketing category
ANDA
Marketing start
2018-11-30
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1543069

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-429-30LIDOCAINE30 g in 1 TUBEOINTMENT303
71205-429-30LIDOCAINE1 in 1 CARTONOINTMENT13
71205-429-44LIDOCAINE1 in 1 CARTONOINTMENT13
71205-429-44LIDOCAINE35.44 g in 1 TUBEOINTMENT35.443
71205-429-52LIDOCAINE35.44 g in 1 TUBEOINTMENT35.443
71205-429-52LIDOCAINE8 in 1 CARTONOINTMENT83
71205-429-64LIDOCAINE240 g in 1 TUBEOINTMENT2403
71205-429-64LIDOCAINE1 in 1 CARTONOINTMENT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-429-30GM - Gram71205-429bb50a53f-5779-475c-b369-2886e6cfd9d912020-05-08
71205-429-44GM - Gram71205-429754f2c40-4783-4cd2-b79c-22f22e66412712024-12-10
71205-429-52GM - Gram71205-429a3694ad0-e899-4afb-a695-d2b2aeb2ce5412024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-429LIDOCAINE OINTMENT [PROFICIENT RX LP]3Current NDC, Legacy NDC, 8 package rows20241010_c98eeb63-c896-4417-b0ad-66c4a87efeee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSNc98eeb63-c896-4417-b0ad-66c4a87efeee3
1543069lidocaine 0.05 MG/MG Topical OintmentSCDc98eeb63-c896-4417-b0ad-66c4a87efeee3
1543069lidocaine 5 % Topical OintmentSYc98eeb63-c896-4417-b0ad-66c4a87efeee3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-429-30712050429301 TUBE in 1 CARTON (71205-429-30) / 30 g in 1 TUBE1 tube2020-03-170000-00-00NoNoCurrent
71205-429-44712050429441 TUBE in 1 CARTON (71205-429-44) / 35.44 g in 1 TUBE1 tube2024-09-13NoNoHistorical
71205-429-52712050429528 TUBE in 1 CARTON (71205-429-52) / 35.44 g in 1 TUBE8 tube2024-10-04NoNoHistorical
71205-429-64712050429641 TUBE in 1 CARTON (71205-429-64) > 240 g in 1 TUBE1 tube2020-03-130000-00-00NoNoCurrent