FDA.reportPublic FDA data

lofexidine hydrochloride

Product NDC
72205-246
11-digit product format
722050246
Labeler code
72205
Product ID
72205-246_19b5c932-af2d-4a0b-ac4a-ba06c53c3219
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lofexidine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA218699
Marketing category
ANDA
Marketing start
2025-02-24
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-246-42lofexidine hydrochloride1 in 1 CARTONTABLET, FILM COATED11
72205-246-42lofexidine hydrochloride36 in 1 BOTTLETABLET, FILM COATED361
72205-246-43lofexidine hydrochloride1 in 1 CARTONTABLET, FILM COATED11
72205-246-43lofexidine hydrochloride96 in 1 BOTTLETABLET, FILM COATED961

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-246-42EA - Each72205-2464db80c10-b057-4d9c-bcc6-c18f367f2c8f12025-05-14
72205-246-43EA - Each72205-246e4a750fd-0af7-415b-825d-59e3a095f6df12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-246LOFEXIDINE HYDROCHLORIDE TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 4 package rows20250309_19b5c932-af2d-4a0b-ac4a-ba06c53c3219.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2046591lofexidine 0.18 MG Oral TabletPSN19b5c932-af2d-4a0b-ac4a-ba06c53c32191
2046591lofexidine 0.18 MG Oral TabletSCD19b5c932-af2d-4a0b-ac4a-ba06c53c32191
2046591lofexidine 0.18 MG (as lofexidine HCl 0.2 MG) Oral TabletSY19b5c932-af2d-4a0b-ac4a-ba06c53c32191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-246-42722050246421 BOTTLE in 1 CARTON (72205-246-42) / 36 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-03-01NoNoCurrent
72205-246-43722050246431 BOTTLE in 1 CARTON (72205-246-43) / 96 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-03-01NoNoCurrent