Home NDC 0904-7266 dexamethasone
Product NDC 0904-7266
11-digit product format 009047266
Labeler code 0904
Product ID 0904-7266_1c4b00a6-64d3-47f1-a206-b84aa969fd37
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dexamethasone
Dosage form TABLET
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA215106
Marketing category ANDA
Marketing start 2021-09-01
Substance DEXAMETHASONE
Active strength 4 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A215106-001 DEXAMETHASONE DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 A215106-002 DEXAMETHASONE DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 · 66 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 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215106-001 DEXAMETHASONE 4MG TABLET / ORAL AB 2021-10-14 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215106-002 DEXAMETHASONE 6MG TABLET / ORAL AB 2021-10-14 6a51e52b5d6a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base dexamethasone
Listing expiration 2027-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197582 Internal RxNorm lookup 197583 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 0904-7266-61 dexamethasone 100 in 1 CARTON TABLET 100 5 0904-7266-61 dexamethasone 1 in 1 BLISTER PACK TABLET 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7266 DEXAMETHASONE TABLET [MAJOR PHARMACEUTICALS] 3 Current NDC, Legacy NDC, 2 package rows 20240829_64b46398-9b97-45e8-b1ba-1a202d574448.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 · 4 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 0904-7266-61 00904726661 100 BLISTER PACK in 1 CARTON (0904-7266-61) / 1 TABLET in 1 BLISTER PACK 100 blister pack 2022-12-02 0000-00-00 No No Current