FDA.reportPublic FDA data

Fludrocortisone Acetate

Product NDC
0115-7033
11-digit product format
001157033
Labeler code
0115
Product ID
0115-7033_1e3aaf68-d0e7-4a70-8ac4-29a9ac4cb037
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUDROCORTISONE ACETATE
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York 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
0115-7033-01Fludrocortisone Acetate100 in 1 BOTTLETABLET10018
0115-7033-02Fludrocortisone Acetate500 in 1 BOTTLETABLET50018
0115-7033-03Fludrocortisone Acetate1000 in 1 BOTTLETABLET100018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-7033-01EA - Each0115-703309bb988c-ee7f-44ce-81d1-f1eebdfa887d12012-07-24
0115-7033-02EA - Each0115-7033425aaaed-933e-4f8d-8887-d1b757431f7f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUDROCORTISONE ACETATEACTIVE INGREDIENTV47IF0PVH4FLUDROCORTISONE ACETATE (FLUDROCORTISONE ACETATE) TABLET [AVPAK]5
FLUDROCORTISONEACTIVE MOIETYU0476M545BFLUDROCORTISONE ACETATE (FLUDROCORTISONE ACETATE) TABLET [AVPAK]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUDROCORTISONE ACETATE (FLUDROCORTISONE ACETATE) TABLET [AVPAK]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUDROCORTISONE ACETATE (FLUDROCORTISONE ACETATE) TABLET [AVPAK]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUDROCORTISONE ACETATE (FLUDROCORTISONE ACETATE) TABLET [AVPAK]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUDROCORTISONE ACETATE (FLUDROCORTISONE ACETATE) TABLET [AVPAK]5
FLUDROCORTISONE ACETATEACTIVE INGREDIENTV47IF0PVH4FLUDROCORTISONE ACETATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]4
FLUDROCORTISONE ACETATEACTIVE INGREDIENTV47IF0PVH4FLUDROCORTISONE ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
FLUDROCORTISONEACTIVE MOIETYU0476M545BFLUDROCORTISONE ACETATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]4
FLUDROCORTISONEACTIVE MOIETYU0476M545BFLUDROCORTISONE ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUDROCORTISONE ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUDROCORTISONE ACETATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUDROCORTISONE ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUDROCORTISONE ACETATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUDROCORTISONE ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUDROCORTISONE ACETATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUDROCORTISONE ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUDROCORTISONE ACETATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]4
FLUDROCORTISONE ACETATEACTIVE INGREDIENTV47IF0PVH4FLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]2
FludrocortisoneACTIVE MOIETYU0476M545BFLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]2
FLUDROCORTISONE ACETATEACTIVE INGREDIENTV47IF0PVH4FLUDROCORTISONE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
FLUDROCORTISONEACTIVE MOIETYU0476M545BFLUDROCORTISONE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUDROCORTISONE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUDROCORTISONE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUDROCORTISONE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUDROCORTISONE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-7033FLUDROCORTISONE ACETATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]17Current NDC, Legacy NDC, 3 package rows20241211_4ed382df-f2d5-46a4-a68b-aba807777093.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
313979fludrocortisone acetate 0.1 MG Oral TabletPSN4ed382df-f2d5-46a4-a68b-aba80777709318
313979fludrocortisone acetate 0.1 MG Oral TabletSCD4ed382df-f2d5-46a4-a68b-aba80777709318
313979fludrocortisone acetate 0.1 MG Oral TabletPSN2cd3965d-cab9-a97c-db61-7d03ced154f313
313979fludrocortisone acetate 0.1 MG Oral TabletSCD2cd3965d-cab9-a97c-db61-7d03ced154f313
313979fludrocortisone acetate 0.1 MG Oral TabletPSN001e72ea-2c9e-468c-90cc-6c347234e2a99
313979fludrocortisone acetate 0.1 MG Oral TabletSCD001e72ea-2c9e-468c-90cc-6c347234e2a99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-7033-0100115703301100 TABLET in 1 BOTTLE (0115-7033-01) 100 tablet2002-03-180000-00-00NoNoCurrent
0115-7033-0200115703302500 TABLET in 1 BOTTLE (0115-7033-02) 500 tablet2002-03-180000-00-00NoNoCurrent
0115-7033-03001157033031000 TABLET in 1 BOTTLE (0115-7033-03) 1000 tablet2002-03-180000-00-00NoNoCurrent