Home NDC 71930-088 fludrocortisone acetate
Product NDC 71930-088
11-digit product format 719300088
Labeler code 71930
Product ID 71930-088_a521d1c2-f4c3-4b7c-ba34-13e06d8ef71b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fludrocortisone acetate
Dosage form TABLET
Route ORAL
Labeler Eywa Pharma Inc
Application ANDA220308
Marketing category ANDA
Marketing start 2025-06-02
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 A220308-001 FLUDROCORTISONE ACETATE FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2026-02-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220308-001 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 A220308-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2026-02-10 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220308-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2026-02-10 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A220308-001 AB 1 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220308-001 AB 1 a50c72e98297…
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 71930-088-12 fludrocortisone acetate 100 in 1 BOTTLE TABLET 100 4 71930-088-13 fludrocortisone acetate 1000 in 1 BOTTLE TABLET 1000 4 71930-088-52 fludrocortisone acetate 500 in 1 BOTTLE TABLET 500 4
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 · 1 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 71930-088-12 71930008812 100 TABLET in 1 BOTTLE (71930-088-12) 100 tablet 2025-06-02 No No Current 71930-088-13 71930008813 1000 in 1 BOTTLE Historical 71930-088-52 71930008852 500 TABLET in 1 BOTTLE (71930-088-52) 500 tablet 2025-06-02 No No Current