Home NDC 49884-086 Dexamethasone
Product NDC 49884-086
11-digit product format 498840086
Labeler code 49884
Product ID 49884-086_957ff54c-e5c0-4709-ae95-89acbba63502
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dexamethasone
Dosage form TABLET
Route ORAL
Labeler Par Pharmaceutical Inc.
Application ANDA088237
Marketing category ANDA
Marketing start 1983-04-28
Marketing end 2020-02-29
Substance DEXAMETHASONE
Active strength 2 mg/1
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49884-086-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49884-086-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 49884-086-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 49884-086-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 49884-086-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 49884-086-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49884-086-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49884-086-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49884-086-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 49884-086-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 49884-086-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 49884-086-01 557ba5c1ecfa…9c80585c8c6e…
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 A088237-001 DEXAMETHASONE DEXAMETHASONE 1.5MG TABLET / ORAL 1983-04-28
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 · 41 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 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL 1983-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL 1983-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL 1983-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL 1983-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL 1983-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL 1983-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL 1983-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL 1983-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL 1983-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL 1983-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL 1983-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL 1983-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL 1983-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088237-001 DEXAMETHASONE 1.5MG TABLET / ORAL BP 1983-04-28 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXAMETHASONE ACTIVE INGREDIENT 7S5I7G3JQL DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.] 4 DEXAMETHASONE ACTIVE MOIETY 7S5I7G3JQL DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.] 4 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.] 4 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.] 4 DEXAMETHASONE ACTIVE INGREDIENT 7S5I7G3JQL DIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX] 3 DEXAMETHASONE ACTIVE MOIETY 7S5I7G3JQL DIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK DIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 DIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP DIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX] 3 DEXAMETHASONE ACTIVE INGREDIENT 7S5I7G3JQL DEXAMETHASONE TABLET [BLENHEIM PHARMACAL, INC.] 1 DEXAMETHASONE ACTIVE MOIETY 7S5I7G3JQL DEXAMETHASONE TABLET [BLENHEIM PHARMACAL, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK DEXAMETHASONE TABLET [BLENHEIM PHARMACAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DEXAMETHASONE TABLET [BLENHEIM PHARMACAL, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 DEXAMETHASONE TABLET [BLENHEIM PHARMACAL, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DEXAMETHASONE TABLET [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DEXAMETHASONE TABLET [BLENHEIM PHARMACAL, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP DEXAMETHASONE TABLET [BLENHEIM PHARMACAL, INC.] 1
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#