FDA.reportPublic FDA data

NDC 50268-330-11 - 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
50268-330
Requested NDC
50268-330-11
Package NDCs from labels
50268-330-11, 50268-330-15
Manufacturer
AvPAK
Effective date
2026-01-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FLUDROCORTISONE ACETATE - AvPAKAvPAK2026-01-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-330-11FLUDROCORTISONE ACETATE1 in 1 BLISTER PACKTABLET113
50268-330-15FLUDROCORTISONE ACETATE50 in 1 BOX, UNIT-DOSETABLET5013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-330FLUDROCORTISONE ACETATE TABLET [AVPAK]12Current NDC, Legacy NDC, 2 package rows20240110_2cd3965d-cab9-a97c-db61-7d03ced154f3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-330-11EA - Each50268-330bb487fc0-b456-47aa-b168-241b42f1efd812015-04-03
50268-330-15EA - Each50268-330b3c1f4cd-5652-4969-badf-fe11761c298612012-07-24

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

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
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
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
ndc (package): 50268-330-11
ndc (package): 50268-330-15
ndc (product): 50268-330
ndc11 (package): 50268033011
rxcui: 313979
spl id: 47e530bb-3b7a-dae5-e063-6394a90a1149
spl set id: 2cd3965d-cab9-a97c-db61-7d03ced154f3
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
rxcui: 313979
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.