Fludrocortisone Acetate

Product NDC
55154-6645
11-digit product format
551546645
Labeler code
55154
Product ID
55154-6645_3ad1aae5-8021-4f12-bad7-5d9ce8810556
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludrocortisone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA040431
Marketing category
ANDA
Marketing start
2008-05-09
Substance
FLUDROCORTISONE ACETATE
Active strength
.1 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
Fludrocortisone Acetate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUDROCORTISONE ACETATE.1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV47IF0PVH4
Rxcui313979

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fff94984-a082-0061-d8a9-f1ca884c7b96Product name320250515

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-6645-0Fludrocortisone Acetate10 in 1 BAGTABLET1015
55154-6645-0Fludrocortisone Acetate1 in 1 BLISTER PACKTABLET115

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUDROCORTISONE ACETATEACTIVE INGREDIENTV47IF0PVH4FLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH]4
FludrocortisoneACTIVE MOIETYU0476M545BFLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-6645FLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH 107, LLC]13Current NDC, Legacy NDC, 2 package rows20241101_89b5687a-6e21-47cd-9c05-d9c9f4f8cf49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313979fludrocortisone acetate 0.1 MG Oral TabletPSN89b5687a-6e21-47cd-9c05-d9c9f4f8cf4915
313979fludrocortisone acetate 0.1 MG Oral TabletSCD89b5687a-6e21-47cd-9c05-d9c9f4f8cf4915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-6645-05515466450010 BLISTER PACK in 1 BAG (55154-6645-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2008-05-090000-00-00NoNoCurrent