NDC 68084-288-11 - 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
68084-288
Requested NDC
68084-288-11
Package NDCs from labels
68084-288-11, 68084-288-01, 68084-288-65
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
Fludrocortisone Acetate - American Health PackagingAmerican Health Packaging2025-05-19HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-288-01Fludrocortisone Acetate100 in 1 BOX, UNIT-DOSETABLET1009
68084-288-11Fludrocortisone Acetate1 in 1 BLISTER PACKTABLET19
68084-288-65Fludrocortisone Acetate50 in 1 CARTONTABLET509

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-288FLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]9Current NDC, Legacy NDC, 3 package rows20250523_001e72ea-2c9e-468c-90cc-6c347234e2a9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-288-01EA - Each68084-288bcf4f7e9-2d86-47f4-bada-0c04a62ce67812012-07-24
68084-288-11EA - Each68084-288e0acd8ce-5a06-4cb5-a5b7-2b15e73b17a612012-07-24
68084-288-65EA - Each68084-28841bcc2e3-8126-4759-81c0-03dd3d1b141812023-02-06

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
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

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
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
ndc (product): 0115-7033
rxcui: 313979
spl id: 1e3aaf68-d0e7-4a70-8ac4-29a9ac4cb037
spl set id: 4ed382df-f2d5-46a4-a68b-aba807777093
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 (package): 68084-288-01
ndc (package): 68084-288-11
ndc (package): 68084-288-65
ndc (product): 68084-288
ndc11 (package): 68084028811
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.