FDA.reportPublic FDA data

Fludrocortisone Acetate

Product NDC
0904-7317
11-digit product format
009047317
Labeler code
0904
Product ID
0904-7317_9e36ef12-d8e2-4a21-a1f0-3bc95fe9e557
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludrocortisone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA215279
Marketing category
ANDA
Marketing start
2024-09-04
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
0904-7317-06Fludrocortisone Acetate1 in 1 BLISTER PACKTABLET12
0904-7317-06Fludrocortisone Acetate50 in 1 CARTONTABLET502
0904-7317-61Fludrocortisone Acetate100 in 1 CARTONTABLET1002
0904-7317-61Fludrocortisone Acetate1 in 1 BLISTER PACKTABLET12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7317-06EA - Each0904-73173e109a2b-3d26-4973-80ec-b6b4756d33e012024-12-10
0904-7317-61EA - Each0904-7317b786dae7-33aa-482c-856d-3713a028f05012024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7317FLUDROCORTISONE ACETATE TABLET [MAJOR PHARMACEUTICALS]1Current NDC, 4 package rows20240906_933e28ef-05e8-419e-a786-21eab67f33a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313979fludrocortisone acetate 0.1 MG Oral TabletPSN3e3b8a1f-ed2a-4235-8a8f-e4ffbe9d1da72
313979fludrocortisone acetate 0.1 MG Oral TabletPSN933e28ef-05e8-419e-a786-21eab67f33a22
313979fludrocortisone acetate 0.1 MG Oral TabletSCD3e3b8a1f-ed2a-4235-8a8f-e4ffbe9d1da72
313979fludrocortisone acetate 0.1 MG Oral TabletSCD933e28ef-05e8-419e-a786-21eab67f33a22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7317-060090473170650 BLISTER PACK in 1 CARTON (0904-7317-06) / 1 TABLET in 1 BLISTER PACK50 blister pack2024-09-04NoNoHistorical
0904-7317-6100904731761100 BLISTER PACK in 1 CARTON (0904-7317-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2024-09-04NoNoHistorical