Home NDC 72789-534 DEXAMETHASONE
Product NDC 72789-534
11-digit product format 727890534
Labeler code 72789
Product ID 72789-534_4589a128-79eb-aa64-e063-6294a90a953b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DEXAMETHASONE
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA218372
Marketing category ANDA
Marketing start 2025-11-21
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 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218372-001 DEXAMETHASONE DEXAMETHASONE 0.5MG TABLET / ORAL AB 2024-09-17 A218372-002 DEXAMETHASONE DEXAMETHASONE 0.75MG TABLET / ORAL AB 2024-09-17 A218372-003 DEXAMETHASONE DEXAMETHASONE 1MG TABLET / ORAL AB 2024-09-17 A218372-004 DEXAMETHASONE DEXAMETHASONE 1.5MG TABLET / ORAL AB 2024-09-17 A218372-005 DEXAMETHASONE DEXAMETHASONE 2MG TABLET / ORAL AB 2024-09-17 A218372-006 DEXAMETHASONE DEXAMETHASONE 4MG TABLET / ORAL AB 2024-09-17 A218372-007 DEXAMETHASONE DEXAMETHASONE 6MG TABLET / ORAL AB 2024-09-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 7 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 3 · 84 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 A218372-001 DEXAMETHASONE 0.5MG TABLET / ORAL AB 2024-09-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218372-002 DEXAMETHASONE 0.75MG TABLET / ORAL AB 2024-09-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218372-003 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-09-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218372-004 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2024-09-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218372-005 DEXAMETHASONE 2MG TABLET / ORAL AB 2024-09-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218372-006 DEXAMETHASONE 4MG TABLET / ORAL AB 2024-09-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218372-007 DEXAMETHASONE 6MG TABLET / ORAL AB 2024-09-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218372-001 DEXAMETHASONE 0.5MG TABLET / ORAL AB 2024-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218372-002 DEXAMETHASONE 0.75MG TABLET / ORAL AB 2024-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218372-003 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218372-004 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2024-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218372-005 DEXAMETHASONE 2MG TABLET / ORAL AB 2024-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218372-006 DEXAMETHASONE 4MG TABLET / ORAL AB 2024-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218372-007 DEXAMETHASONE 6MG TABLET / ORAL AB 2024-09-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218372-001 DEXAMETHASONE 0.5MG TABLET / ORAL AB 2024-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218372-002 DEXAMETHASONE 0.75MG TABLET / ORAL AB 2024-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218372-003 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218372-004 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2024-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218372-005 DEXAMETHASONE 2MG TABLET / ORAL AB 2024-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218372-006 DEXAMETHASONE 4MG TABLET / ORAL AB 2024-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218372-007 DEXAMETHASONE 6MG TABLET / ORAL AB 2024-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218372-001 DEXAMETHASONE 0.5MG TABLET / ORAL AB 2024-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218372-002 DEXAMETHASONE 0.75MG TABLET / ORAL AB 2024-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218372-003 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218372-004 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2024-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218372-005 DEXAMETHASONE 2MG TABLET / ORAL AB 2024-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218372-006 DEXAMETHASONE 4MG TABLET / ORAL AB 2024-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218372-007 DEXAMETHASONE 6MG TABLET / ORAL AB 2024-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218372-001 DEXAMETHASONE 0.5MG TABLET / ORAL AB 2024-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218372-002 DEXAMETHASONE 0.75MG TABLET / ORAL AB 2024-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218372-003 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218372-004 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2024-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218372-005 DEXAMETHASONE 2MG TABLET / ORAL AB 2024-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218372-006 DEXAMETHASONE 4MG TABLET / ORAL AB 2024-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218372-007 DEXAMETHASONE 6MG TABLET / ORAL AB 2024-09-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218372-001 DEXAMETHASONE 0.5MG TABLET / ORAL AB 2024-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218372-002 DEXAMETHASONE 0.75MG TABLET / ORAL AB 2024-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218372-003 DEXAMETHASONE 1MG TABLET / ORAL AB 2024-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218372-004 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2024-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218372-005 DEXAMETHASONE 2MG TABLET / ORAL AB 2024-09-17 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 72789-534-01 DEXAMETHASONE 100 in 1 BOTTLE, PLASTIC TABLET 100 4 72789-534-28 DEXAMETHASONE 28 in 1 BOTTLE, PLASTIC TABLET 28 4 72789-534-95 DEXAMETHASONE 1000 in 1 BOTTLE, PLASTIC TABLET 1000 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 · 3 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 72789-534-01 72789053401 100 TABLET in 1 BOTTLE, PLASTIC (72789-534-01) 100 tablet 2025-11-21 No No Current 72789-534-28 72789053428 28 TABLET in 1 BOTTLE, PLASTIC (72789-534-28) 28 tablet 2025-12-09 No No Current 72789-534-95 72789053495 1000 TABLET in 1 BOTTLE, PLASTIC (72789-534-95) 1000 tablet 2025-11-21 No No Current