Home NDC 71205-703 Dexamethasone
Product NDC 71205-703
11-digit product format 712050703
Labeler code 71205
Product ID 71205-703_6f917c55-034a-40c5-9011-0e10e94d0eba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dexamethasone
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA088481
Marketing category ANDA
Marketing start 2021-06-28
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 1 .
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 · 164 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 2026-02-19 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…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
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 71205-703-20 Dexamethasone 20 in 1 BOTTLE TABLET 20 1 71205-703-30 Dexamethasone 30 in 1 BOTTLE TABLET 30 1 71205-703-60 Dexamethasone 60 in 1 BOTTLE TABLET 60 1 71205-703-90 Dexamethasone 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-703 DEXAMETHASONE TABLET [PROFICIENT RX LP] 1 Current NDC, Legacy NDC, 4 package rows 20221007_6f917c55-034a-40c5-9011-0e10e94d0eba.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 Marketing end Sample Exclude flag Status 71205-703-20 71205070320 20 TABLET in 1 BOTTLE (71205-703-20) 20 tablet 2022-10-04 0000-00-00 No No Current 71205-703-30 71205070330 30 TABLET in 1 BOTTLE (71205-703-30) 30 tablet 2022-10-04 0000-00-00 No No Current 71205-703-60 71205070360 60 TABLET in 1 BOTTLE (71205-703-60) 60 tablet 2022-10-04 0000-00-00 No No Current 71205-703-90 71205070390 90 TABLET in 1 BOTTLE (71205-703-90) 90 tablet 2022-10-04 0000-00-00 No No Current