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| DECADRON | DEXAMETHASONE | TABLET;ORAL | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DECADRON | DEXAMETHASONE | TABLET;ORAL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DECADRON | DEXAMETHASONE | TABLET;ORAL | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DECADRON | DEXAMETHASONE | TABLET;ORAL | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DECADRON | DEXAMETHASONE | TABLET;ORAL | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DECADRON | DEXAMETHASONE | TABLET;ORAL | 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| N011664-001 | DECADRON | DEXAMETHASONE | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011664-002 | DECADRON | DEXAMETHASONE | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011664-003 | DECADRON | DEXAMETHASONE | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011664-004 | DECADRON | DEXAMETHASONE | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011664-005 | DECADRON | DEXAMETHASONE | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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 | Preferred Pharmaceuticals Inc. | 64577454-d49e-4180-99e6-8461f74b0221 | 2026-01-20 | Warnings, Adverse reactions | DEXAMETHASONE |
| DEXAMETHASONE | DEXAMETHASONE | Bryant Ranch Prepack | 075717e3-be2a-4bb3-bead-492761bfb287 | 2026-01-09 | Warnings, Adverse reactions | DEXAMETHASONE |
| Hemady | DEXAMETHASONE | Edenbridge Pharmaceuticals LLC. | 6b9cf32c-6d60-4853-bbfd-2304ffc2c129 | 2026-01-09 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Northwind Health Company, LLC | aa30086a-8551-413e-9cf2-6393093cfcfd | 2025-12-26 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Golden State Medical Supply, Inc. | a7455c92-41ce-4e87-e053-2995a90a610f | 2025-12-11 | Warnings, Adverse reactions | DEXAMETHASONE |
| DEXAMETHASONE | DEXAMETHASONE | PD-Rx Pharmaceuticals, Inc. | a8d6792e-757e-4dc6-adf5-0d9211075428 | 2025-12-09 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | ANI Pharmaceuticals, Inc. | 5d9b22ca-c619-4ee3-98eb-74544d0d5cb3 | 2025-12-04 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Kesin Pharma Corporation | 43e2a24a-4465-5787-e063-6394a90a0b81 | 2025-11-18 | Warnings, Adverse reactions | DEXAMETHASONE |
| DEXAMETHASONE | DEXAMETHASONE | Kanchan Healthcare Inc | 02f7bf9c-1aa3-4734-8a3e-1f49498055d7 | 2025-11-12 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Proficient Rx LP | 429d0d32-a1ff-481b-b4e9-c0b17b3610a1 | 2025-11-01 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Advanced Rx Pharmacy of Tennessee, LLC | 01cfaa3e-5e30-18fa-e063-6394a90a084e | 2025-10-29 | Warnings, Adverse reactions | DEXAMETHASONE |
| DEXAMETHASONE | DEXAMETHASONE | Advagen Pharma Ltd. | 3c1729db-8ba3-4cba-9eff-ab4ae2c061c2 | 2025-10-22 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | PD-Rx Pharmaceuticals, Inc. | 2ceb3a01-f5bb-4538-b5c1-cea400901d02 | 2025-10-15 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Apotex Corp. | bfaa71cb-e517-8d94-f64b-8cdbf7b8fbf2 | 2025-09-17 | Warnings, Adverse reactions | DEXAMETHASONE |
| dexamethasone | DEXAMETHASONE | Major Pharmaceuticals | 5ec5b0e6-7fa8-4afc-97a4-d185484ada8b | 2025-09-08 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Rising Pharma Holdings, Inc. | 7cf5c17c-a80b-4547-83b2-0d53e2b933f7 | 2025-09-05 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | A-S Medication Solutions | 16c59e9a-8e4f-4300-bbbb-bcc982c18fc8 | 2025-08-15 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | A-S Medication Solutions | 89af5591-eebf-44e7-827f-ce3b123123e4 | 2025-08-15 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | NuCare Pharmaceuticals,Inc. | 141e16a7-1f3d-3943-e063-6294a90ac5a9 | 2025-07-30 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone Intensol | DEXAMETHASONE INTENSOL | Hikma Pharmaceuticals USA, Inc. | b15200fb-1826-472b-a907-e677a272513b | 2025-06-06 | Warnings, Adverse reactions | DEXAMETHASONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.