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| DECADRON | DEXAMETHASONE | TABLET;ORAL | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DECADRON | DEXAMETHASONE | TABLET;ORAL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DECADRON | DEXAMETHASONE | TABLET;ORAL | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DECADRON | DEXAMETHASONE | TABLET;ORAL | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DECADRON | DEXAMETHASONE | TABLET;ORAL | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DECADRON | DEXAMETHASONE | TABLET;ORAL | 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| N011664-001 | DECADRON | DEXAMETHASONE | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011664-002 | DECADRON | DEXAMETHASONE | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011664-003 | DECADRON | DEXAMETHASONE | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011664-004 | DECADRON | DEXAMETHASONE | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011664-005 | DECADRON | DEXAMETHASONE | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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 | REMEDYREPACK INC. | 8c5375a7-7a0d-4af0-8b86-bc87698ac3d1 | 2026-09-04 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Sportpharm LLC | a37486b9-4323-41fc-ac7e-869d95dc9568 | 2026-07-17 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | REMEDYREPACK INC. | f5c9b70b-b835-4f3b-9643-0aec50a0d3f2 | 2026-07-07 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Pangea Pharmaceuticals, LLC | a41e6e26-9ebb-4b06-866e-a24af21c644c | 2026-06-29 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | PD-Rx Pharmaceuticals, Inc. | 89e1d458-7caa-430f-9c54-360889899a73 | 2026-06-12 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | PD-Rx Pharmaceuticals, Inc. | 736861fa-1df8-4afd-ba4a-dd7d7bffd865 | 2026-06-12 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Preferred Pharmaceuticals Inc | 79b65fd4-16a5-42e0-b041-61d7bda0a5ff | 2026-06-08 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | REMEDYREPACK INC. | 8deaaaf7-3efd-4065-b29f-e5ef038030f8 | 2026-06-01 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Cardinal Health 107, LLC | bf8acfdb-8dc8-4a69-90b0-33c680c421d6 | 2026-05-15 | Warnings, Adverse reactions | DEXAMETHASONE |
| dexamethasone | DEXAMETHASONE | Cardinal Health 107, LLC | 5622f8d2-1893-441b-8011-fa90c8a63b0b | 2026-05-05 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Sportpharm LLC | 12d19271-867b-41ae-a6d2-7e8de3637011 | 2026-04-24 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Pangea Pharmaceuticals, LLC | 37607468-0331-44c0-9bb4-5c614c7b69d4 | 2026-04-19 | Warnings, Adverse reactions | DEXAMETHASONE |
| dexamethasone | DEXAMETHASONE | Preferred Pharmaceuticals Inc. | 4c619d48-8cf9-4085-8405-c8f066bce19c | 2026-04-01 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Preferred Pharmaceuticals, Inc. | c4d1e578-a1d2-4d5e-8426-6b2c39f0d9bd | 2026-04-01 | Warnings, Adverse reactions | DEXAMETHASONE |
| dexamethasone | DEXAMETHASONE | Major Pharmaceuticals | 64b46398-9b97-45e8-b1ba-1a202d574448 | 2026-03-26 | Warnings, Adverse reactions | DEXAMETHASONE |
| OZURDEX | DEXAMETHASONE | Allergan, Inc. | 4b204f44-6e8a-4d17-803c-268f0b04679f | 2026-03-11 | Warnings, Adverse reactions | DEXAMETHASONE |
| DEXAMETHASONE | DEXAMETHASONE | NuCare Pharmaceuticals, Inc. | 4a808dd5-35b7-e879-e063-6394a90a0bf7 | 2026-02-10 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Direct_Rx | 0a0db8e7-8474-3d08-e063-6294a90af3f5 | 2026-02-06 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Bryant Ranch Prepack | e830be9d-0a8c-4712-93c6-284c208d6f0d | 2026-02-05 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Bryant Ranch Prepack | b3217057-5945-452c-aa99-ab696fd8b5e7 | 2026-02-04 | Warnings, Adverse reactions | DEXAMETHASONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.