Home NDC 50090-6152 Dexamethasone
Product NDC 50090-6152
11-digit product format 500906152
Labeler code 50090
Product ID 50090-6152_c9ddcfff-39d8-4b6a-92d0-105f4d225466
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexamethasone
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA080399
Marketing category ANDA
Marketing start 2022-04-30
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A080399-001 DEXAMETHASONE DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 A080399-002 DEXAMETHASONE DEXAMETHASONE 4MG TABLET / ORAL AB 2022-04-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A080399-002 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.
Product history page 1 of 2 · 70 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 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A080399-002 DEXAMETHASONE 4MG TABLET / ORAL AB 2022-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080399-002 DEXAMETHASONE 4MG TABLET / ORAL AB 2022-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A080399-002 DEXAMETHASONE 4MG TABLET / ORAL AB 2022-04-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080399-002 DEXAMETHASONE 4MG TABLET / ORAL AB 2022-04-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080399-002 DEXAMETHASONE 4MG TABLET / ORAL AB 2022-04-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080399-002 DEXAMETHASONE 4MG TABLET / ORAL AB 2022-04-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080399-002 DEXAMETHASONE 4MG TABLET / ORAL AB 2022-04-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080399-002 DEXAMETHASONE 4MG TABLET / ORAL AB 2022-04-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080399-002 DEXAMETHASONE 4MG TABLET / ORAL AB 2022-04-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A080399-002 DEXAMETHASONE 4MG TABLET / ORAL AB 2022-04-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A080399-002 DEXAMETHASONE 4MG TABLET / ORAL AB 2022-04-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A080399-002 DEXAMETHASONE 4MG TABLET / ORAL AB 2022-04-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A080399-002 DEXAMETHASONE 4MG TABLET / ORAL AB 2022-04-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A080399-002 DEXAMETHASONE 4MG TABLET / ORAL AB 2022-04-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A080399-002 DEXAMETHASONE 4MG TABLET / ORAL AB 2022-04-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A080399-001 DEXAMETHASONE 0.75MG TABLET / ORAL Approved before 1982 3f01610625f2…
Observed Orange Book normalized TE history# 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 50090-6152-0 Dexamethasone 28 in 1 BOTTLE TABLET 28 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6152 DEXAMETHASONE TABLET [A-S MEDICATION SOLUTIONS] 1 Current NDC, 1 package rows 20230421_16c59e9a-8e4f-4300-bbbb-bcc982c18fc8.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 · 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 50090-6152-0 50090615200 28 TABLET in 1 BOTTLE (50090-6152-0) 28 tablet 2022-10-05 No No Current