Dexamethasone
- Product NDC
- 53217-231
- 11-digit product format
- 532170231
- Labeler code
- 53217
- Product ID
- 53217-231_5d41f6a4-d047-4fb9-ba0d-c795c9875f7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexamethasone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA084613
- Marketing category
- ANDA
- Marketing start
- 1975-06-03
- Marketing end
- 0000-00-00
- Substance
- DEXAMETHASONE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|---|---|---|---|---|
| 53217-231-21 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6241-f424-e053-dadaa90a57ce | Dexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate) |
| 53217-231-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6241-f424-e053-dadaa90a57ce | Dexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate) |
| 53217-231-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6241-f424-e053-dadaa90a57ce | Dexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate) |
| 53217-231-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6241-f424-e053-dadaa90a57ce | Dexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53217-231-21 | Dexamethasone | 21 in 1 BOTTLE | TABLET | 21 | 1 | |
| 53217-231-30 | Dexamethasone | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 53217-231-60 | Dexamethasone | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 53217-231-90 | Dexamethasone | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 343033 | dexAMETHasone 0.75 MG Oral Tablet | PSN | 55d94620-bb62-4f78-9dc5-cb705b79020f | 1 |
| 343033 | dexamethasone 0.75 MG Oral Tablet | SCD | 55d94620-bb62-4f78-9dc5-cb705b79020f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53217-231-21 | 53217023121 | 21 in 1 BOTTLE | Historical |
| 53217-231-30 | 53217023130 | 30 in 1 BOTTLE | Historical |
| 53217-231-60 | 53217023160 | 60 in 1 BOTTLE | Historical |
| 53217-231-90 | 53217023190 | 90 in 1 BOTTLE | Historical |