Home NDC 55154-2644 Fludrocortisone Acetate
Product NDC 55154-2644
11-digit product format 551542644
Labeler code 55154
Product ID 55154-2644_8fd21358-b22c-451f-bfb7-f456bbde63a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fludrocortisone Acetate
Dosage form TABLET
Route ORAL
Labeler Cardinal Health 107, LLC
Application ANDA215279
Marketing category ANDA
Marketing start 2025-02-25
Substance FLUDROCORTISONE ACETATE
Active strength .1 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215279-001 FLUDROCORTISONE ACETATE FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215279-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215279-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2022-05-31 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fludrocortisone Acetate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUDROCORTISONE ACETATE .1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V47IF0PVH4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313979 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55154-2644-0 Fludrocortisone Acetate 10 in 1 BAG TABLET 10 2 55154-2644-0 Fludrocortisone Acetate 1 in 1 BLISTER PACK TABLET 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-2644 FLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH 107, LLC] 1 Current NDC, 2 package rows 20250227_3e3b8a1f-ed2a-4235-8a8f-e4ffbe9d1da7.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 · 5 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55154-2644-0 55154264400 10 BLISTER PACK in 1 BAG (55154-2644-0) / 1 TABLET in 1 BLISTER PACK 10 blister pack 2025-02-25 No No Current