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| DECADRON | DEXAMETHASONE | TABLET;ORAL | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DECADRON | DEXAMETHASONE | TABLET;ORAL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DECADRON | DEXAMETHASONE | TABLET;ORAL | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DECADRON | DEXAMETHASONE | TABLET;ORAL | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DECADRON | DEXAMETHASONE | TABLET;ORAL | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DECADRON | DEXAMETHASONE | TABLET;ORAL | 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| N011664-001 | DECADRON | DEXAMETHASONE | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011664-002 | DECADRON | DEXAMETHASONE | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011664-003 | DECADRON | DEXAMETHASONE | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011664-004 | DECADRON | DEXAMETHASONE | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011664-005 | DECADRON | DEXAMETHASONE | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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 | Advanced Rx of Tennessee, LLC | 348f5a56-978d-4272-e063-6294a90afdb6 | 2025-05-07 | Warnings, Adverse reactions | DEXAMETHASONE |
| MAXIDEX | DEXAMETHASONE | Harrow Eye, LLC | 35e47fcd-e020-43e5-8322-41f8060d220d | 2025-05-05 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | PD-Rx Pharmaceuticals, Inc. | a5609df4-4933-4f85-a7b8-bc54a70a2bac | 2025-04-30 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Marlex Pharmaceuticals, Inc | 7b51ffce-ec64-4b49-8870-b9666537c541 | 2025-04-22 | Warnings, Adverse reactions | DEXAMETHASONE |
| DEXTENZA | DEXAMETHASONE | Ocular Therapeutix, Inc. | 7514e6b8-c33f-4fbf-8810-ef520e1eb4bd | 2025-04-18 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Proficient Rx LP | 3f2fe98a-ab42-4bec-bf97-c090567f9ad6 | 2025-04-01 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Bionpharma Inc., | 401ec088-984a-49ab-b317-747c2b9b9e22 | 2025-03-05 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Bionpharma Inc., | 3166db4f-66a5-496a-a194-3cc01b7347d3 | 2025-03-05 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Preferred Pharmaceuticals Inc. | b883860c-27ba-4bac-8ae3-4cf4d82d5071 | 2025-02-10 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Prasco Laboratories | bfce6b49-f7ff-4ec7-9580-b730f0a207d7 | 2025-02-01 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Redpharm Drug, Inc. | 115e1bfb-1697-d567-e063-6394a90a78e5 | 2025-01-23 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Direct_Rx | e90cb7f5-5e99-fbf3-e053-2995a90a70aa | 2025-01-22 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Direct_Rx | fade983c-81fb-df94-e053-6394a90a7560 | 2025-01-22 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Direct_Rx | 044d7898-4ab6-a0b3-e063-6294a90acdba | 2025-01-22 | Warnings, Adverse reactions | DEXAMETHASONE |
| DEXAMETHASONE | DEXAMETHASONE | Direct Rx | cc7140de-a205-f675-e053-2995a90ac22b | 2025-01-20 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Preferred Pharmaceuticals Inc. | 955db121-79f4-47eb-8c10-01b2d8b411e4 | 2025-01-13 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Advanced Rx Pharmacy of Tennessee, LLC | fa16db27-3c8c-eb22-e053-6394a90add59 | 2024-12-31 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | American Health Packaging | 23deb5f1-d357-45af-9851-d1249bdfa6dd | 2024-12-05 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Bryant Ranch Prepack | e652b041-2a0b-4bcd-a420-5d026302edbb | 2024-09-23 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Direct_rx | 214dea63-d77a-922a-e063-6294a90a967e | 2024-09-04 | Warnings, Adverse reactions | DEXAMETHASONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.