FDA.reportPublic FDA data

NDC 0143-1246-01 - 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
0143-1246
Requested NDC
0143-1246-01
Package NDCs from labels
0143-1246-01, 0143-1246-30
Manufacturer
West-ward Pharmaceutical Corp
Effective date
2011-07-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fludrocortisone Acetate - West-ward Pharmaceutical CorpWest-ward Pharmaceutical Corp2011-07-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-1246-01Fludrocortisone Acetate100 in 1 BOTTLETABLET1002
0143-1246-30Fludrocortisone Acetate30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-1246FLUDROCORTISONE ACETATE TABLET [WEST-WARD PHARMACEUTICAL CORP]2Legacy NDC, 2 package rows20110801_198278e7-9a6d-4a9a-bb47-3589f35939da.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUDROCORTISONE ACETATEACTIVE INGREDIENTV47IF0PVH4FLUDROCORTISONE ACETATE TABLET [WEST-WARD PHARMACEUTICAL CORP]2
FLUDROCORTISONEACTIVE MOIETYU0476M545BFLUDROCORTISONE ACETATE TABLET [WEST-WARD PHARMACEUTICAL CORP]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKFLUDROCORTISONE ACETATE TABLET [WEST-WARD PHARMACEUTICAL CORP]2
CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIEDINACTIVE INGREDIENTQG4MW19XYXFLUDROCORTISONE ACETATE TABLET [WEST-WARD PHARMACEUTICAL CORP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUDROCORTISONE ACETATE TABLET [WEST-WARD PHARMACEUTICAL CORP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUDROCORTISONE ACETATE TABLET [WEST-WARD PHARMACEUTICAL CORP]2
TALCINACTIVE INGREDIENT7SEV7J4R1UFLUDROCORTISONE ACETATE TABLET [WEST-WARD PHARMACEUTICAL CORP]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 19 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
rxcui: 313979
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
rxcui: 313979
unii: V47IF0PVH4
Fludrocortisone AcetateFLUDROCORTISONE ACETATEAvKAREb8ce5b7e-7aa2-45f8-e053-2995a90a6c652026-01-15Warnings, Adverse reactionsExact identifier
rxcui: 313979
unii: V47IF0PVH4
FLUDROCORTISONE ACETATEFLUDROCORTISONE ACETATEAvPAK2cd3965d-cab9-a97c-db61-7d03ced154f32026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 313979
unii: V47IF0PVH4
Fludrocortisone AcetateFLUDROCORTISONE ACETATEAmneal Pharmaceuticals of New York LLC4ed382df-f2d5-46a4-a68b-aba8077770932025-12-20Warnings, Adverse reactionsExact identifier
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
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 7SEV7J4R1U
Fludrocortisone AcetateFLUDROCORTISONE ACETATEAmerican Health Packaging001e72ea-2c9e-468c-90cc-6c347234e2a92025-05-19Warnings, Adverse reactionsExact identifier
rxcui: 313979
unii: V47IF0PVH4
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
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
18cc54af-63ba-47f7-a805-66b2da1f522e198278e7-9a6d-4a9a-bb47-3589f35939da2011-07-26Warnings, Adverse reactionsExact identifier
spl id: 18cc54af-63ba-47f7-a805-66b2da1f522e
spl set id: 198278e7-9a6d-4a9a-bb47-3589f35939da

Reported adverse events (FAERS/openFDA)#

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