FDA.reportPublic FDA data

NDC 69238-7033-05 - 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
69238-7033
Requested NDC
69238-7033-05
Package NDCs from labels
69238-7033-1, 69238-7033-5, 69238-7033-05
Manufacturer
Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals of New York, LLC
Effective date
2024-02-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fludrocortisone Acetate Tablets, USP (0.1 mg)Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals of New York, LLC2024-02-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-7033-1Fludrocortisone Acetate100 in 1 BOTTLETABLET1004
69238-7033-5Fludrocortisone Acetate500 in 1 BOTTLETABLET5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-7033FLUDROCORTISONE ACETATE TABLET [AMNEAL PHARMACEUTICALS NY LLC]4Current NDC, Legacy NDC, 2 package rows20240210_51363453-6d33-4aee-8426-37ac0bf3cc10.zip

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
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
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
ndc (package): 69238-7033-1
ndc (package): 69238-7033-5
ndc (product): 69238-7033
ndc11 (package): 69238703305
rxcui: 313979
spl id: 0c6f4e43-c7f8-4bd7-9e9c-f40f83bfd353
spl set id: 51363453-6d33-4aee-8426-37ac0bf3cc10
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.