FDA.reportPublic FDA data

Lofexidine

Product NDC
71921-250
11-digit product format
719210250
Labeler code
71921
Product ID
71921-250_f742254f-781e-4e7a-ae0b-e79b8482980d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lofexidine
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Florida Pharmaceutical Products, LLC
Application
ANDA218613
Marketing category
ANDA
Marketing start
2024-08-21
Substance
LOFEXIDINE HYDROCHLORIDE
Active strength
.18 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOFEXIDINE HYDROCHLORIDE.18 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
71921-250-36Lofexidine1 in 1 CARTONTABLET, COATED13
71921-250-36Lofexidine36 in 1 BOTTLETABLET, COATED363
71921-250-96Lofexidine96 in 1 BOTTLETABLET, COATED963
71921-250-96Lofexidine1 in 1 CARTONTABLET, COATED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71921-250-36EA - Each71921-250023040ab-0726-4b52-bad2-a449a3649d4612024-09-09
71921-250-96EA - Each71921-25023315e57-a57b-4a19-b44f-e5537ef84d7212024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71921-250LOFEXIDINE TABLET, COATED [FLORIDA PHARMACEUTICAL PRODUCTS, LLC]1Current NDC, 4 package rows20240822_ce4488e2-842c-45ba-aca7-075a900e2a1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2046591lofexidine 0.18 MG Oral TabletPSNce4488e2-842c-45ba-aca7-075a900e2a1c3
2046591lofexidine 0.18 MG Oral TabletSCDce4488e2-842c-45ba-aca7-075a900e2a1c3
2046591lofexidine 0.18 MG (as lofexidine HCl 0.2 MG) Oral TabletSYce4488e2-842c-45ba-aca7-075a900e2a1c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71921-250-36719210250361 BOTTLE in 1 CARTON (71921-250-36) / 36 TABLET, COATED in 1 BOTTLE1 bottle2024-08-21NoNoHistorical
71921-250-96719210250961 BOTTLE in 1 CARTON (71921-250-96) / 96 TABLET, COATED in 1 BOTTLE1 bottle2024-08-21NoNoHistorical