Dexamethasone
- Product NDC
- 69452-277
- 11-digit product format
- 694520277
- Labeler code
- 69452
- Product ID
- 69452-277_2f9dcbaf-165e-5594-e063-6394a90a9dc5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexamethasone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bionpharma Inc.,
- Application
- ANDA217001
- Marketing category
- ANDA
- Marketing start
- 2023-08-01
- Substance
- DEXAMETHASONE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dexamethasone
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXAMETHASONE | 4 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 7S5I7G3JQL |
| Rxcui | 197582, 197583 |
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 |
|---|---|---|---|---|---|---|
| 69452-277-20 | Dexamethasone | 100 in 1 BOTTLE | TABLET | 100 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69452-277-20 | EA - Each | 69452-277 | 1a8dc2c9-139e-4497-96cb-b6400161833c | 1 | 2023-10-16 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197582 | dexAMETHasone 4 MG Oral Tablet | PSN | 3166db4f-66a5-496a-a194-3cc01b7347d3 | 3 |
| 197583 | dexAMETHasone 6 MG Oral Tablet | PSN | 3166db4f-66a5-496a-a194-3cc01b7347d3 | 3 |
| 197582 | dexamethasone 4 MG Oral Tablet | SCD | 3166db4f-66a5-496a-a194-3cc01b7347d3 | 3 |
| 197583 | dexamethasone 6 MG Oral Tablet | SCD | 3166db4f-66a5-496a-a194-3cc01b7347d3 | 3 |
| 197582 | dexAMETHasone 4 MG Oral Tablet | PSN | 348f5a56-978d-4272-e063-6294a90afdb6 | 1 |
| 197582 | dexAMETHasone 4 MG Oral Tablet | PSN | 429d0d32-a1ff-481b-b4e9-c0b17b3610a1 | 1 |
| 197582 | dexAMETHasone 4 MG Oral Tablet | PSN | b883860c-27ba-4bac-8ae3-4cf4d82d5071 | 1 |
| 197582 | dexAMETHasone 4 MG Oral Tablet | PSN | e652b041-2a0b-4bcd-a420-5d026302edbb | 1 |
| 197582 | dexamethasone 4 MG Oral Tablet | SCD | 348f5a56-978d-4272-e063-6294a90afdb6 | 1 |
| 197582 | dexamethasone 4 MG Oral Tablet | SCD | 429d0d32-a1ff-481b-b4e9-c0b17b3610a1 | 1 |
| 197582 | dexamethasone 4 MG Oral Tablet | SCD | b883860c-27ba-4bac-8ae3-4cf4d82d5071 | 1 |
| 197582 | dexamethasone 4 MG Oral Tablet | SCD | e652b041-2a0b-4bcd-a420-5d026302edbb | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69452-277-20 | 69452027720 | 100 TABLET in 1 BOTTLE (69452-277-20) | 100 tablet | 2023-08-01 | No | No | Current |