Fludrocortisone Acetate

Product NDC
68084-288
11-digit product format
680840288
Labeler code
68084
Product ID
68084-288_35818f71-8d18-1daa-e063-6394a90aeb9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludrocortisone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA040431
Marketing category
ANDA
Marketing start
2008-09-05
Substance
FLUDROCORTISONE ACETATE
Active strength
.1 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
Fludrocortisone Acetate
Listing expiration
2026-12-31

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
68084-288-01Fludrocortisone Acetate100 in 1 BOX, UNIT-DOSETABLET1009
68084-288-11Fludrocortisone Acetate1 in 1 BLISTER PACKTABLET19
68084-288-65Fludrocortisone Acetate50 in 1 CARTONTABLET509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-288-01EA - Each68084-288bcf4f7e9-2d86-47f4-bada-0c04a62ce67812012-07-24
68084-288-11EA - Each68084-288e0acd8ce-5a06-4cb5-a5b7-2b15e73b17a612012-07-24
68084-288-65EA - Each68084-28841bcc2e3-8126-4759-81c0-03dd3d1b141812023-02-06

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
FLUDROCORTISONE ACETATEACTIVE INGREDIENTV47IF0PVH4FLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]2
FludrocortisoneACTIVE MOIETYU0476M545BFLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-288FLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]9Current NDC, Legacy NDC, 3 package rows20250523_001e72ea-2c9e-468c-90cc-6c347234e2a9.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
313979fludrocortisone acetate 0.1 MG Oral TabletPSN001e72ea-2c9e-468c-90cc-6c347234e2a99
313979fludrocortisone acetate 0.1 MG Oral TabletSCD001e72ea-2c9e-468c-90cc-6c347234e2a99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-288-0168084028801100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-288-01) / 1 TABLET in 1 BLISTER PACK (68084-288-11) 100 blister pack2008-09-050000-00-00NoNoCurrent
68084-288-11680840288111 in 1 BLISTER PACKHistorical
68084-288-656808402886550 BLISTER PACK in 1 CARTON (68084-288-65) / 1 TABLET in 1 BLISTER PACK (68084-288-11) 50 blister pack2023-02-09NoNoCurrent