Home NDC 71335-2108 Dexamethasone
Product NDC 71335-2108
11-digit product format 713352108
Labeler code 71335
Product ID 71335-2108_47ef46ae-6174-4863-8d17-303cb456d663
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dexamethasone
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA088481
Marketing category ANDA
Marketing start 2021-06-28
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A088481-001 DEXAMETHASONE DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 A088481-002 DEXAMETHASONE DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 A088481-003 DEXAMETHASONE DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 A088481-004 DEXAMETHASONE DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 164 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 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088481-001 DEXAMETHASONE 6MG TABLET / ORAL AB 1983-11-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A088481-002 DEXAMETHASONE 0.5MG TABLET / ORAL BP 1983-04-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A088481-003 DEXAMETHASONE 0.75MG TABLET / ORAL BP 1983-04-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A088481-004 DEXAMETHASONE 4MG TABLET / ORAL AB 1983-04-28 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-2108 DEXAMETHASONE TABLET [BRYANT RANCH PREPACK] 103 Current NDC, Legacy NDC, 10 package rows 20240420_36f104ba-80b4-4713-aa74-f80483b7bded.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 · 5 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 71335-2108-0 71335210800 4 TABLET in 1 BOTTLE (71335-2108-0) 4 tablet 2023-05-04 0000-00-00 No No Current 71335-2108-1 71335210801 30 TABLET in 1 BOTTLE (71335-2108-1) 30 tablet 2023-02-03 0000-00-00 No No Current 71335-2108-2 71335210802 6 TABLET in 1 BOTTLE (71335-2108-2) 6 tablet 2022-06-09 0000-00-00 No No Current 71335-2108-3 71335210803 3 TABLET in 1 BOTTLE (71335-2108-3) 3 tablet 2022-08-25 0000-00-00 No No Current 71335-2108-4 71335210804 15 TABLET in 1 BOTTLE (71335-2108-4) 15 tablet 2022-08-09 0000-00-00 No No Current 71335-2108-5 71335210805 40 TABLET in 1 BOTTLE (71335-2108-5) 40 tablet 2024-04-03 0000-00-00 No No Current 71335-2108-6 71335210806 60 TABLET in 1 BOTTLE (71335-2108-6) 60 tablet 2024-04-03 0000-00-00 No No Current 71335-2108-7 71335210807 28 TABLET in 1 BOTTLE (71335-2108-7) 28 tablet 2023-02-10 0000-00-00 No No Current 71335-2108-8 71335210808 90 TABLET in 1 BOTTLE (71335-2108-8) 90 tablet 2024-04-03 0000-00-00 No No Current 71335-2108-9 71335210809 10 TABLET in 1 BOTTLE (71335-2108-9) 10 tablet 2022-08-01 0000-00-00 No No Current