Home NDC 67296-1837 Dexamethasone
Product NDC 67296-1837
11-digit product format 672961837
Labeler code 67296
Product ID 67296-1837_2c62e68c-c777-9851-e063-6394a90af20b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dexamethasone
Dosage form TABLET
Route ORAL
Labeler Redpharm Drug, Inc.
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 67296-1837-1 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 67296-1837-1 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 67296-1837-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 67296-1837-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 67296-1837-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 67296-1837-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 67296-1837-1 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 67296-1837-1 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 67296-1837-1 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67296-1837-4 Dexamethasone 4 in 1 BOTTLE TABLET 4 3 67296-1837-1 Dexamethasone 10 in 1 BOTTLE TABLET 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67296-1837 DEXAMETHASONE TABLET [REDPHARM DRUG, INC.] 3 Current NDC, 1 package rows 20250124_115e1bfb-1697-d567-e063-6394a90a78e5.zip 67296-1837 DEXAMETHASONE TABLET [REDPHARM DRUG, INC.] 1 Current NDC, 1 package rows 20230205_f3d1f760-562f-09b2-e053-2a95a90a7f42.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 Sample Exclude flag Status 67296-1837-1 67296183701 10 in 1 BOTTLE Historical 67296-1837-4 67296183704 4 TABLET in 1 BOTTLE (67296-1837-4) 4 tablet 2021-08-30 No No Current