Fludrocortisone Acetate

Product NDC
0615-6562
11-digit product format
006156562
Labeler code
0615
Product ID
0615-6562_8ee49c80-0201-4532-a8b7-918fbd031ff4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUDROCORTISONE ACETATE
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0615-6562-392020-11-17C16284748780-19d75b9d0-b48b-f424-e053-dadaa90a57ceFludrocortisone Acetate Tablets, USP (0.1 mg)
0615-6562-392020-01-31C16284748780-19d75b9d0-b48b-f424-e053-dadaa90a57ceFludrocortisone Acetate Tablets, USP (0.1 mg)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-6562-39Fludrocortisone Acetate30 in 1 BLISTER PACKTABLET3019

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-6562FLUDROCORTISONE ACETATE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]7Current NDC, Legacy NDC, 1 package rows20250108_3c007f9a-4cd5-4e74-a633-d55dde1fe903.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313979fludrocortisone acetate 0.1 MG Oral TabletPSN3c007f9a-4cd5-4e74-a633-d55dde1fe90319
313979fludrocortisone acetate 0.1 MG Oral TabletSCD3c007f9a-4cd5-4e74-a633-d55dde1fe90319

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-6562-390061565623930 TABLET in 1 BLISTER PACK (0615-6562-39) 30 tablet2020-10-070000-00-00NoNoCurrent