Dexamethasone Tablets, USP
- Manufacturer
- Zydus Lifesciences Limited
- Effective date
- 2024-05-13
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 21:03:37
Label at a glance#
Label contents#
Full prescribing information#
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXAMETHASONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1ea46721-9071-6b81-fd0a-a82bfbb014ec | Product name | 7 | 20250220 |
| 525701df-f985-480d-995a-e0ee70c2bdf4 | Product name | 5 | 20250128 |
| ea50b939-d92a-4100-84f5-1c1089663837 | Product name | 2 | 20240705 |
| 941f67d9-7f03-56d2-750c-36de24f654db | Product name | 3 | 20221117 |
| d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8 | Product name | 2 | 20220506 |
| 7b2c58e8-5850-4e3e-82e9-b1593b1de761 | Product name | 5 | 20220210 |
| 81e34474-b0a5-434f-8104-25d689efc99e | Product name | 1 | 20200303 |
| 05ab9c01-cd9a-4f59-b2e8-ddcb887cac39 | Product name | 1 | 20190408 |
| 0c7dba41-c919-5809-508d-4affe6cfcff2 | Product name | 2 | 20170817 |
| 399647c0-db89-02d1-991c-0c17b584482c | Product name | 1 | 20140508 |
| 3e9a6377-704f-dff7-b19f-56c98d40c444 | Product name | 1 | 20140508 |
| 4d2e6ff9-14f5-b84f-c39b-373b005712c1 | Product name | 1 | 20140508 |
| 725d71bf-f956-5cad-e556-fa39cb060dc8 | Product name | 1 | 20140508 |
| 9ea85abb-fa68-5da6-ab60-2c7eef579000 | Product name | 1 | 20140508 |
| d029211e-5e6b-725f-3696-ac6ff77da222 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70771-1706-1 | Dexamethasone | 100 in 1 BOTTLE | TABLET | 100 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70771-1706 | DEXAMETHASONE TABLET [ZYDUS LIFESCIENCES LIMITED] | 1 | Current NDC, 1 package rows | 20240517_e9012a11-6219-4272-aea2-b7328bbcf523.zip |
Products#
Every source-derived product name is available through these pages.
- Dexamethasone
- FERRIC OXIDE YELLOW
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
- STARCH, CORN
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70771-1706 | 70771-1706-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXAMETHASONE | 7S5I7G3JQL | ACTIB |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SUCROSE | C151H8M554 | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216284-001 | DEXAMETHASONE | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2024-05-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A216284-001 | AB |
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 | A216284-001 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2024-05-09 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A216284-001 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2024-05-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216284-001 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2024-05-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216284-001 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2024-05-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216284-001 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2024-05-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216284-001 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2024-05-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216284-001 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2024-05-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216284-001 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2024-05-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216284-001 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2024-05-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216284-001 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2024-05-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216284-001 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2024-05-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216284-001 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2024-05-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216284-001 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2024-05-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216284-001 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2024-05-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216284-001 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2024-05-09 | 1e350fbaab3a… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216284-001 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2024-05-09 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A216284-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A216284-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A216284-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216284-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A216284-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216284-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216284-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216284-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216284-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216284-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216284-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A216284-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216284-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216284-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216284-001 | AB | 1 | 1e350fbaab3a… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216284-001 | AB | 1 | a50c72e98297… |
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 | Zydus Lifesciences Limited | e9012a11-6219-4272-aea2-b7328bbcf523 | 2024-05-13 | 70771-1706-1 70771-1706 70771170601 232c68af-fb83-4b93-9e16-9803c8e680c0 e9012a11-6219-4272-aea2-b7328bbcf523 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
