Fludrocortisone Acetate

Product NDC
0555-0997
11-digit product format
005550997
Labeler code
0555
Product ID
0555-0997_85d41b6a-4c27-475e-9d87-dc647962239c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludrocortisone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA040425
Marketing category
ANDA
Marketing start
2003-02-14
Marketing end
0000-00-00
Substance
FLUDROCORTISONE ACETATE
Active strength
0 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-0997-02EA - Each0555-09971bb6bc27-2914-4c5d-9137-65c22415631f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUDROCORTISONE ACETATEACTIVE INGREDIENTV47IF0PVH4FLUDROCORTISONE ACETATE TABLET [BARR LABORATORIES INC.]7
FLUDROCORTISONEACTIVE MOIETYU0476M545BFLUDROCORTISONE ACETATE TABLET [BARR LABORATORIES INC.]7
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FLUDROCORTISONE ACETATE TABLET [BARR LABORATORIES INC.]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKFLUDROCORTISONE ACETATE TABLET [BARR LABORATORIES INC.]7
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPFLUDROCORTISONE ACETATE TABLET [BARR LABORATORIES INC.]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUDROCORTISONE ACETATE TABLET [BARR LABORATORIES INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUDROCORTISONE ACETATE TABLET [BARR LABORATORIES INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FLUDROCORTISONE ACETATE TABLET [BARR LABORATORIES INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUDROCORTISONE ACETATE TABLET [BARR LABORATORIES INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UFLUDROCORTISONE ACETATE TABLET [BARR LABORATORIES INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-0997FLUDROCORTISONE ACETATE TABLET [TEVA PHARMACEUTICALS USA, INC.]15Legacy NDC20240717_f5cffa20-9a22-43c5-9e89-3225852c2dfa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-0997-0200555099702100 TABLET in 1 BOTTLE (0555-0997-02) 100 tablet2003-02-140000-00-00NoNoCurrent