Fludrocortisone Acetate

Product NDC
69238-7033
11-digit product format
692387033
Labeler code
69238
Product ID
69238-7033_0c6f4e43-c7f8-4bd7-9e9c-f40f83bfd353
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUDROCORTISONE ACETATE
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA040431
Marketing category
ANDA
Marketing start
2002-03-18
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
69238-7033-1Fludrocortisone Acetate100 in 1 BOTTLETABLET1004
69238-7033-5Fludrocortisone Acetate500 in 1 BOTTLETABLET5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-7033FLUDROCORTISONE ACETATE TABLET [AMNEAL PHARMACEUTICALS NY LLC]4Current NDC, Legacy NDC, 2 package rows20240210_51363453-6d33-4aee-8426-37ac0bf3cc10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313979fludrocortisone acetate 0.1 MG Oral TabletPSN51363453-6d33-4aee-8426-37ac0bf3cc104
313979fludrocortisone acetate 0.1 MG Oral TabletSCD51363453-6d33-4aee-8426-37ac0bf3cc104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-7033-169238703301100 TABLET in 1 BOTTLE (69238-7033-1) 100 tablet2002-03-180000-00-00NoNoCurrent
69238-7033-569238703305500 TABLET in 1 BOTTLE (69238-7033-5) 500 tablet2002-03-180000-00-00NoNoCurrent