Fludrocortisone acetate

Product NDC
72578-164
11-digit product format
725780164
Labeler code
72578
Product ID
72578-164_4b107dc9-d932-49db-87ed-66df936588d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludrocortisone acetate
Dosage form
TABLET
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA219251
Marketing category
ANDA
Marketing start
2024-12-02
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
72578-164-01Fludrocortisone acetate100 in 1 BOTTLETABLET1001
72578-164-05Fludrocortisone acetate500 in 1 BOTTLETABLET5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-164-01EA - Each72578-164e9c69316-5abe-49e3-b6d0-188073bb550a12025-02-10
72578-164-05EA - Each72578-16415988a33-3009-4a0a-8963-ac29540f834112025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-164FLUDROCORTISONE ACETATE TABLET [VIONA PHARMACEUTICALS INC]1Current NDC, 2 package rows20241203_bc92f5c6-3a65-4fab-85b3-fd5b84f917c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313979fludrocortisone acetate 0.1 MG Oral TabletPSN3752ff25-8887-5c88-e063-6294a90a345a2
313979fludrocortisone acetate 0.1 MG Oral TabletSCD3752ff25-8887-5c88-e063-6294a90a345a2
313979fludrocortisone acetate 0.1 MG Oral TabletPSNbc92f5c6-3a65-4fab-85b3-fd5b84f917c11
313979fludrocortisone acetate 0.1 MG Oral TabletSCDbc92f5c6-3a65-4fab-85b3-fd5b84f917c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72578-164-0172578016401100 TABLET in 1 BOTTLE (72578-164-01) 100 tablet2024-12-02NoNoHistorical
72578-164-0572578016405500 TABLET in 1 BOTTLE (72578-164-05) 500 tablet2024-12-02NoNoHistorical