FDA.reportPublic FDA data

Lofexidine hydrochloride

Product NDC
66993-345
11-digit product format
669930345
Labeler code
66993
Product ID
66993-345_b317fb7f-8a02-4d11-9d20-401644e5d6ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lofexidine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Prasco Laboratories
Application
NDA209229
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-08-29
Substance
LOFEXIDINE HYDROCHLORIDE
Active strength
.2 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lofexidine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOFEXIDINE HYDROCHLORIDE.2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV47G1SDI1B
Rxcui2046591

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3e49fde7-51ed-4b66-8350-88f7c4d066d4Product name220250317

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66993-345-37Lofexidine hydrochloride36 in 1 BOTTLETABLET, FILM COATED363
66993-345-37Lofexidine hydrochloride1 in 1 CARTONTABLET, FILM COATED13
66993-345-76Lofexidine hydrochloride1 in 1 CARTONTABLET, FILM COATED13
66993-345-76Lofexidine hydrochloride96 in 1 BOTTLETABLET, FILM COATED963

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-345-37EA - Each66993-345407530f7-b7cf-41e9-a487-84f17ab34b6812024-09-09
66993-345-76EA - Each66993-345095de77c-d06e-46e7-b0b5-a3c80cd61da512024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-345LOFEXIDINE HYDROCHLORIDE TABLET, FILM COATED [PRASCO LABORATORIES]3Current NDC, 4 package rows20240921_77367dfa-434f-4d61-95fe-f0f1628457d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2046591lofexidine 0.18 MG Oral TabletPSN77367dfa-434f-4d61-95fe-f0f1628457d13
2046591lofexidine 0.18 MG Oral TabletSCD77367dfa-434f-4d61-95fe-f0f1628457d13
2046591lofexidine 0.18 MG (as lofexidine HCl 0.2 MG) Oral TabletSY77367dfa-434f-4d61-95fe-f0f1628457d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66993-345-37669930345371 BOTTLE in 1 CARTON (66993-345-37) / 36 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-08-29NoNoCurrent
66993-345-76669930345761 BOTTLE in 1 CARTON (66993-345-76) / 96 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-08-29NoNoCurrent