Dexamethasone
- Product NDC
- 61919-269
- 11-digit product format
- 619190269
- Labeler code
- 61919
- Product ID
- 61919-269_a848991f-8647-3fde-e053-2995a90aa17e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexamethasone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct Rx
- Application
- ANDA088237
- Marketing category
- ANDA
- Marketing start
- 2015-01-01
- Marketing end
- 0000-00-00
- Substance
- DEXAMETHASONE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61919-269-21 | 2025-01-30 | C162847 | 48780-1 | 1030e365-4de8-111a-e063-dadaa90a10e2 | Dexamethasone |
| 61919-269-55 | 2025-01-30 | C162847 | 48780-1 | 1030e365-4de8-111a-e063-dadaa90a10e2 | Dexamethasone |
| 61919-269-21 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4de8-111a-e063-dadaa90a10e2 | Dexamethasone |
| 61919-269-55 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4de8-111a-e063-dadaa90a10e2 | Dexamethasone |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-269-21 | Dexamethasone | 21 in 1 BOTTLE | TABLET | 21 | 8 | |
| 61919-269-55 | Dexamethasone | 55 in 1 BOTTLE | TABLET | 55 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-269-21 | EA - Each | 61919-269 | 9496c4e1-e02e-4cb8-b21d-c3be380f01f7 | 1 | 2015-09-10 |
| 61919-269-55 | EA - Each | 61919-269 | 6fd555e8-724a-457a-b2bf-d7c82c2434f6 | 1 | 2015-09-10 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| DEXAMETHASONE | ACTIVE INGREDIENT | 7S5I7G3JQL | DIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX] | 3 | |
| DEXAMETHASONE | ACTIVE MOIETY | 7S5I7G3JQL | DIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX] | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | DIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | DIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | DIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | DIRECT RX (DEXAMETHASONE) TABLET [DIRECT RX] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197580 | dexAMETHasone 1.5 MG Oral Tablet | PSN | 3ff06262-4c6f-4423-99fa-b4d8191ea133 | 8 |
| 197580 | dexamethasone 1.5 MG Oral Tablet | SCD | 3ff06262-4c6f-4423-99fa-b4d8191ea133 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61919-269-21 | 61919026921 | 21 TABLET in 1 BOTTLE (61919-269-21) | 21 tablet | 2020-01-01 | 0000-00-00 | No | No | Current |
| 61919-269-55 | 61919026955 | 55 TABLET in 1 BOTTLE (61919-269-55) | 55 tablet | 2020-01-01 | 0000-00-00 | No | No | Current |