Home NDC 51407-705-01 Fludrocortisone acetate
Product NDC 51407-705
Requested package NDC 51407-705-01
11-digit product format 514070705
Labeler code 51407
Product ID 51407-705_3d863fa4-bdeb-e0a4-e063-6294a90a7cc4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fludrocortisone acetate
Dosage form TABLET
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA219251
Marketing category ANDA
Marketing start 2024-10-16
Substance FLUDROCORTISONE ACETATE
Active strength .1 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
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 A219251-001 FLUDROCORTISONE ACETATE FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219251-001 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 A219251-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219251-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219251-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219251-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219251-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A219251-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A219251-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A219251-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219251-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Fludrocortisone acetate
Listing expiration 2026-12-31 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 51407-705-01 Fludrocortisone acetate 100 in 1 BOTTLE TABLET 100 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51407-705-01 51407070501 100 TABLET in 1 BOTTLE (51407-705-01) 100 tablet 2025-06-10 No No Current