Home NDC 55154-4315 dexamethasone
Product NDC 55154-4315
11-digit product format 551544315
Labeler code 55154
Product ID 55154-4315_50a6b52b-5ad5-4482-8606-8741a28271cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dexamethasone
Dosage form TABLET
Route ORAL
Labeler Cardinal Health 107, LLC
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 · 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 55154-4315-0 dexamethasone 1 in 1 BLISTER PACK TABLET 1 5 55154-4315-0 dexamethasone 10 in 1 BAG TABLET 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-4315 DEXAMETHASONE TABLET [CARDINAL HEALTH 107, LLC] 3 Current NDC, 2 package rows 20241219_5622f8d2-1893-441b-8011-fa90c8a63b0b.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 Sample Exclude flag Status 55154-4315-0 55154431500 10 BLISTER PACK in 1 BAG (55154-4315-0) / 1 TABLET in 1 BLISTER PACK 10 blister pack 2023-08-01 No No Current