Home NDC 0904-7444 dexamethasone
Product NDC 0904-7444
11-digit product format 009047444
Labeler code 0904
Product ID 0904-7444_7a409708-7462-4a75-8d0b-6054f3523ac9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dexamethasone
Dosage form TABLET
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA216295
Marketing category ANDA
Marketing start 2024-08-26
Substance DEXAMETHASONE
Active strength 2 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216295-001 DEXAMETHASONE DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216295-001 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 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216295-001 DEXAMETHASONE 2MG TABLET / ORAL AB 2022-09-08 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-12-20 04:57 UTC 2023-12 A216295-001 CGT 2023-03-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216295-001 CGT 2023-03-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216295-001 CGT 2023-03-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216295-001 CGT 2023-03-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216295-001 CGT 2023-03-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216295-001 CGT 2023-03-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216295-001 CGT 2023-03-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216295-001 CGT 2023-03-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A216295-001 CGT 2023-03-08 f41ea6bd6efb…
Additional Listing Data#
Finished product Yes
Brand name base dexamethasone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXAMETHASONE 2 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 197581 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 0904-7444-61 dexamethasone 100 in 1 CARTON TABLET 100 2 0904-7444-61 dexamethasone 1 in 1 BLISTER PACK TABLET 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7444 DEXAMETHASONE TABLET [MAJOR PHARMACEUTICALS] 1 Current NDC, 2 package rows 20240829_5ec5b0e6-7fa8-4afc-97a4-d185484ada8b.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 · 2 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 0904-7444-61 00904744461 100 BLISTER PACK in 1 CARTON (0904-7444-61) / 1 TABLET in 1 BLISTER PACK 100 blister pack 2024-08-26 No No Current