Application 011664
- Type
- NDA
- Sponsor
- MERCK
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DECADRON | DEXAMETHASONE | TABLET;ORAL | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | DECADRON | DEXAMETHASONE | TABLET;ORAL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | DECADRON | DEXAMETHASONE | TABLET;ORAL | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | DECADRON | DEXAMETHASONE | TABLET;ORAL | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | DECADRON | DEXAMETHASONE | TABLET;ORAL | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 006 | DECADRON | DEXAMETHASONE | TABLET;ORAL | 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N011664-001 | DECADRON | DEXAMETHASONE | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011664-002 | DECADRON | DEXAMETHASONE | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011664-003 | DECADRON | DEXAMETHASONE | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011664-004 | DECADRON | DEXAMETHASONE | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011664-005 | DECADRON | DEXAMETHASONE | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011664-006 | DECADRON | DEXAMETHASONE | 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-07-30 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N011664-001 | DECADRON | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N011664-002 | DECADRON | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N011664-003 | DECADRON | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N011664-004 | DECADRON | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N011664-005 | DECADRON | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N011664-006 | DECADRON | 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-07-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N011664-001 | DECADRON | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011664-002 | DECADRON | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011664-003 | DECADRON | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011664-004 | DECADRON | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011664-005 | DECADRON | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011664-006 | DECADRON | 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-07-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N011664-001 | DECADRON | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011664-002 | DECADRON | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011664-003 | DECADRON | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011664-004 | DECADRON | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011664-005 | DECADRON | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011664-006 | DECADRON | 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-07-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011664-001 | DECADRON | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011664-002 | DECADRON | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011664-003 | DECADRON | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011664-004 | DECADRON | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011664-005 | DECADRON | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011664-006 | DECADRON | 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-07-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N011664-001 | DECADRON | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011664-002 | DECADRON | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011664-003 | DECADRON | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011664-004 | DECADRON | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011664-005 | DECADRON | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011664-006 | DECADRON | 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-07-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011664-001 | DECADRON | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011664-002 | DECADRON | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011664-003 | DECADRON | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011664-004 | DECADRON | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011664-005 | DECADRON | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011664-006 | DECADRON | 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-07-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011664-001 | DECADRON | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011664-002 | DECADRON | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011664-003 | DECADRON | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011664-004 | DECADRON | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dexamethasone | DEXAMETHASONE | Proficient Rx LP | 45fd8030-dbe3-4da4-9d0a-6549cf4f7359 | 2024-07-01 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Bryant Ranch Prepack | 710ce0fc-78b3-402d-a2ca-e5eda09f3211 | 2024-06-11 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Bryant Ranch Prepack | c75360d3-2e4f-4620-a8f0-db28b1aa704b | 2024-05-28 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Zydus Lifesciences Limited | e9012a11-6219-4272-aea2-b7328bbcf523 | 2024-05-13 | DEXAMETHASONE | |
| Dexamethasone | DEXAMETHASONE | Viona Pharmaceuticals Inc | 360d3af0-8f69-4e82-ab5f-1f70cc2025d4 | 2024-05-13 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | NuCare Pharmaceuticals,Inc. | 17f56402-331e-2e3d-e063-6394a90acc0e | 2024-05-08 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Bryant Ranch Prepack | 36f104ba-80b4-4713-aa74-f80483b7bded | 2024-04-03 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Viona Pharmaceuticals Inc | 93bb34a7-c8ca-4dab-b2a0-cbe011e1090c | 2024-03-30 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Zydus Lifesciences Limited | 1e84a609-22a0-41b9-83a0-c45019c8cf9a | 2024-03-30 | DEXAMETHASONE | |
| Dexamethasone | DEXAMETHASONE | Zydus Lifesciences Limited | 522a1a49-5540-4245-a15f-e3cdc0a97a5e | 2024-03-30 | DEXAMETHASONE | |
| Dexamethasone | DEXAMETHASONE | Viona Pharmaceuticals Inc | 86afd383-7d6b-48f0-a803-9446fa1ded10 | 2024-03-29 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Chartwell RX, LLC | 3746066a-3c87-4238-945a-6dfb4d01a072 | 2024-03-14 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | NorthStar Rx LLC | 05c77a4c-c508-babd-e063-6294a90a450a | 2024-03-08 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | ANI Pharmaceuticals, Inc. | fe8cf911-84ef-47be-acb8-0501b546299b | 2024-03-04 | Warnings, Adverse reactions | DEXAMETHASONE |
| dexamethasone | DEXAMETHASONE | Amneal Pharmaceuticals NY LLC | ac71f888-c83a-46a5-921c-1ebdf6cfadc1 | 2024-02-21 | Warnings, Adverse reactions | DEXAMETHASONE |
| dexamethasone | DEXAMETHASONE | Amneal Pharmaceuticals NY LLC | b9eb9a30-c1da-4d38-8ea8-616a254e2afc | 2024-02-21 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Alvogen Inc. | 9ab26af9-8196-e3d3-76a3-75227fd4e1c3 | 2024-02-21 | Warnings, Adverse reactions | DEXAMETHASONE |
| DEXAMETHASONE | DEXAMETHASONE | Direct Rx | 3ff06262-4c6f-4423-99fa-b4d8191ea133 | 2024-01-09 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Proficient Rx LP | 6f917c55-034a-40c5-9011-0e10e94d0eba | 2022-10-01 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Proficient Rx LP | 99296e80-3ca6-4430-9ef7-adca357c31b3 | 2022-06-01 | Warnings, Adverse reactions | DEXAMETHASONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.