Home NDC 80425-0328 Dexamethasone
Product NDC 80425-0328
11-digit product format 804250328
Labeler code 80425
Product ID 80425-0328_2a9bfe6a-6d71-b262-e063-6294a90a1cf3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexamethasone
Dosage form TABLET
Route ORAL
Labeler Advanced Rx Pharmacy of Tennessee, LLC
Application ANDA088481
Marketing category ANDA
Marketing start 2023-04-24
Substance DEXAMETHASONE
Active strength 4 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A088481-001 DEXAMETHASONE DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 A088481-002 DEXAMETHASONE DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 A088481-003 DEXAMETHASONE DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 A088481-004 DEXAMETHASONE DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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.
Product history page 1 of 5 · 172 observed 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 2026-09-14 22:38:34 2026-08 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Dexamethasone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXAMETHASONE 4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7S5I7G3JQL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197582 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 80425-0328-1 Dexamethasone 12 in 1 BOTTLE TABLET 12 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0328 DEXAMETHASONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC] 2 Current NDC, 1 package rows 20250102_fa16db27-3c8c-eb22-e053-6394a90add59.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 80425-0328-1 80425032801 12 TABLET in 1 BOTTLE (80425-0328-1) 12 tablet 2023-04-24 No No Current