FDA.reportPublic FDA data

NDC 55154-6645-00 - Fludrocortisone Acetate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
55154-6645
Requested NDC
55154-6645-00
Package NDCs from labels
55154-6645-0, 55154-6645-00
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fludrocortisone Acetate - Cardinal Health 107, LLCCardinal Health 107, LLC2026-05-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-6645-0Fludrocortisone Acetate10 in 1 BAGTABLET1015
55154-6645-0Fludrocortisone Acetate1 in 1 BLISTER PACKTABLET115

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-6645FLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH 107, LLC]13Current NDC, Legacy NDC, 2 package rows20241101_89b5687a-6e21-47cd-9c05-d9c9f4f8cf49.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUDROCORTISONE ACETATEACTIVE INGREDIENTV47IF0PVH4FLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH]4
FludrocortisoneACTIVE MOIETYU0476M545BFLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH]4

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fludrocortisone AcetateFLUDROCORTISONE ACETATEMajor Pharmaceuticals933e28ef-05e8-419e-a786-21eab67f33a22026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 313979
unii: V47IF0PVH4
Fludrocortisone AcetateFLUDROCORTISONE ACETATECardinal Health 107, LLC89b5687a-6e21-47cd-9c05-d9c9f4f8cf492026-05-15Warnings, Adverse reactionsExact identifier
application number: ANDA040431
ndc (package): 55154-6645-0
ndc (product): 55154-6645
ndc11 (package): 55154664500
rxcui: 313979
spl id: 3ad1aae5-8021-4f12-bad7-5d9ce8810556
spl set id: 89b5687a-6e21-47cd-9c05-d9c9f4f8cf49
unii: V47IF0PVH4
fludrocortisone acetateFLUDROCORTISONE ACETATEEywa Pharma Inceff2eae8-94ce-46ca-a027-6b1d08e7b96b2026-05-13Warnings, Adverse reactionsExact identifier
rxcui: 313979
unii: V47IF0PVH4
Fludrocortisone AcetateFLUDROCORTISONE ACETATECardinal Health 107, LLC3e3b8a1f-ed2a-4235-8a8f-e4ffbe9d1da72026-05-06Warnings, Adverse reactionsExact identifier
rxcui: 313979
unii: V47IF0PVH4
Fludrocortisone AcetateFLUDROCORTISONE ACETATENCS HealthCare of KY, LLC dba Vangard Labs3c007f9a-4cd5-4e74-a633-d55dde1fe9032026-02-27Warnings, Adverse reactionsExact identifier
application number: ANDA040431
rxcui: 313979
unii: V47IF0PVH4
Fludrocortisone AcetateFLUDROCORTISONE ACETATEAvKAREb8ce5b7e-7aa2-45f8-e053-2995a90a6c652026-01-15Warnings, Adverse reactionsExact identifier
application number: ANDA040431
rxcui: 313979
unii: V47IF0PVH4
FLUDROCORTISONE ACETATEFLUDROCORTISONE ACETATEAvPAK2cd3965d-cab9-a97c-db61-7d03ced154f32026-01-08Warnings, Adverse reactionsExact identifier
application number: ANDA040431
rxcui: 313979
unii: V47IF0PVH4
Fludrocortisone AcetateFLUDROCORTISONE ACETATEAmneal Pharmaceuticals of New York LLC4ed382df-f2d5-46a4-a68b-aba8077770932025-12-20Warnings, Adverse reactionsExact identifier
application number: ANDA040431
rxcui: 313979
unii: V47IF0PVH4
Fludrocortisone acetateFLUDROCORTISONE ACETATEGolden State Medical Supply, Inc.3752ff25-8887-5c88-e063-6294a90a345a2025-08-29Warnings, Adverse reactionsExact identifier
rxcui: 313979
unii: V47IF0PVH4
Fludrocortisone AcetateFLUDROCORTISONE ACETATEAmerican Health Packaging001e72ea-2c9e-468c-90cc-6c347234e2a92025-05-19Warnings, Adverse reactionsExact identifier
application number: ANDA040431
ndc (product): 68084-288
rxcui: 313979
spl id: 35818f71-8d18-1daa-e063-6394a90aeb9f
spl set id: 001e72ea-2c9e-468c-90cc-6c347234e2a9
unii: V47IF0PVH4
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Fludrocortisone acetateFLUDROCORTISONE ACETATEZydus Lifesciences Limited6c4a7d2d-00a4-4d80-ab4c-2afd4e4f614e2024-10-29Warnings, Adverse reactionsExact identifier
rxcui: 313979
unii: V47IF0PVH4
Fludrocortisone AcetateFLUDROCORTISONE ACETATEBryant Ranch Prepack3d6f1a89-ea11-474d-aaca-64fea02a3beb2024-07-30Warnings, Adverse reactionsExact identifier
rxcui: 313979
unii: V47IF0PVH4
Fludrocortisone acetateFLUDROCORTISONE ACETATEViona Pharmaceuticals Incbc92f5c6-3a65-4fab-85b3-fd5b84f917c12024-07-13Warnings, Adverse reactionsExact identifier
rxcui: 313979
unii: V47IF0PVH4
Fludrocortisone AcetateFLUDROCORTISONE ACETATEAmneal Pharmaceuticals NY LLC51363453-6d33-4aee-8426-37ac0bf3cc102024-02-09Warnings, Adverse reactionsExact identifier
application number: ANDA040431
rxcui: 313979
unii: V47IF0PVH4
Fludrocortisone AcetateFLUDROCORTISONE ACETATENorthStar Rx LLC04ad6ba3-6781-b5df-e063-6294a90a7e6e2023-09-07Warnings, Adverse reactionsExact identifier
rxcui: 313979
unii: V47IF0PVH4
Fludrocortisone AcetateFLUDROCORTISONE ACETATENovitium Pharma LLC96dbbf53-962b-49a4-a60d-91ae0b9fb9ff2022-06-03Warnings, Adverse reactionsExact identifier
rxcui: 313979
unii: V47IF0PVH4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.