FDA.reportPublic FDA data

FLUDROCORTISONE ACETATE

Product NDC
50268-330
11-digit product format
502680330
Labeler code
50268
Product ID
50268-330_47e530bb-3b7a-dae5-e063-6394a90a1149
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUDROCORTISONE ACETATE
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA040431
Marketing category
ANDA
Marketing start
2011-08-01
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
50268-330-11FLUDROCORTISONE ACETATE1 in 1 BLISTER PACKTABLET113
50268-330-15FLUDROCORTISONE ACETATE50 in 1 BOX, UNIT-DOSETABLET5013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-330-11EA - Each50268-330bb487fc0-b456-47aa-b168-241b42f1efd812015-04-03
50268-330-15EA - Each50268-330b3c1f4cd-5652-4969-badf-fe11761c298612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUDROCORTISONE ACETATEACTIVE INGREDIENTV47IF0PVH4FLUDROCORTISONE ACETATE (FLUDROCORTISONE ACETATE) TABLET [AVPAK]5
FLUDROCORTISONEACTIVE MOIETYU0476M545BFLUDROCORTISONE ACETATE (FLUDROCORTISONE ACETATE) TABLET [AVPAK]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUDROCORTISONE ACETATE (FLUDROCORTISONE ACETATE) TABLET [AVPAK]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUDROCORTISONE ACETATE (FLUDROCORTISONE ACETATE) TABLET [AVPAK]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUDROCORTISONE ACETATE (FLUDROCORTISONE ACETATE) TABLET [AVPAK]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUDROCORTISONE ACETATE (FLUDROCORTISONE ACETATE) TABLET [AVPAK]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-330FLUDROCORTISONE ACETATE TABLET [AVPAK]12Current NDC, Legacy NDC, 2 package rows20240110_2cd3965d-cab9-a97c-db61-7d03ced154f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313979fludrocortisone acetate 0.1 MG Oral TabletPSN2cd3965d-cab9-a97c-db61-7d03ced154f313
313979fludrocortisone acetate 0.1 MG Oral TabletSCD2cd3965d-cab9-a97c-db61-7d03ced154f313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-330-11502680330111 in 1 BLISTER PACKHistorical
50268-330-155026803301550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-330-15) / 1 TABLET in 1 BLISTER PACK (50268-330-11) 50 blister pack2011-08-010000-00-00NoNoCurrent