Fludrocortisone Acetate

Product NDC
42291-764
11-digit product format
422910764
Labeler code
42291
Product ID
42291-764_487504b1-ef26-c343-e063-6294a90a8bf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUDROCORTISONE ACETATE
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA040431
Marketing category
ANDA
Marketing start
2021-01-13
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
42291-764-01Fludrocortisone Acetate100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-764-01EA - Each42291-7649f54b7aa-d3c9-44f5-b357-77de2d85981812021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-764FLUDROCORTISONE ACETATE TABLET [AVKARE]3Current NDC, Legacy NDC, 1 package rows20240111_b8ce5b7e-7aa2-45f8-e053-2995a90a6c65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313979fludrocortisone acetate 0.1 MG Oral TabletPSNb8ce5b7e-7aa2-45f8-e053-2995a90a6c654
313979fludrocortisone acetate 0.1 MG Oral TabletSCDb8ce5b7e-7aa2-45f8-e053-2995a90a6c654

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-764-0142291076401100 TABLET in 1 BOTTLE (42291-764-01) 100 tablet2021-01-130000-00-00NoNoCurrent