TaperDex 12-day
- Product NDC
- 42195-490
- 11-digit product format
- 421950490
- Labeler code
- 42195
- Product ID
- 42195-490_450c31b5-c5c0-44bb-bde5-66748f67b156
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DEXAMETHASONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Xspire Pharma, Llc
- Application
- ANDA088237
- Marketing category
- ANDA
- Marketing start
- 2018-01-19
- Marketing end
- 0000-00-00
- Substance
- DEXAMETHASONE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|---|---|---|---|---|
| 42195-490-12 | 2024-01-30 | C162847 | 48780-1 | 1030e365-268a-111a-e063-dadaa90a10e2 | TaperDex 12-day DEXAMETHASONE TABLETS USP, 1.5 mg Rx Only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42195-490-12 | TaperDex 12-day | 1 in 1 CARTON | TABLET | 1 | 4 | |
| 42195-490-12 | TaperDex 12-day | 49 in 1 BLISTER PACK | TABLET | 49 | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1998481 | {49 (dexamethasone 1.5 MG Oral Tablet) } Pack [TaperDex 12 Day Taper] | BPCK | c3c59b82-1343-470d-bbc7-e40da3c0a28f | 4 |
| 1943550 | {49 (dexamethasone 1.5 MG Oral Tablet) } Pack | GPCK | c3c59b82-1343-470d-bbc7-e40da3c0a28f | 4 |
| 197580 | dexAMETHasone 1.5 MG Oral Tablet | PSN | c3c59b82-1343-470d-bbc7-e40da3c0a28f | 4 |
| 1943550 | dexAMETHasone 1.5 MG Tablet 12 Day 49 Count Pack | PSN | c3c59b82-1343-470d-bbc7-e40da3c0a28f | 4 |
| 1998481 | TaperDex 1.5 MG Tablet 12 Day 49 Count Pack | PSN | c3c59b82-1343-470d-bbc7-e40da3c0a28f | 4 |
| 197580 | dexamethasone 1.5 MG Oral Tablet | SCD | c3c59b82-1343-470d-bbc7-e40da3c0a28f | 4 |
| 1943550 | dexamethasone 1.5 MG Tablet 12 Day 49 Count Pack | SY | c3c59b82-1343-470d-bbc7-e40da3c0a28f | 4 |
| 1998481 | TaperDex 12 Day Taper Pack | SY | c3c59b82-1343-470d-bbc7-e40da3c0a28f | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 42195-490-12 | 42195049012 | 1 BLISTER PACK in 1 CARTON (42195-490-12) > 49 TABLET in 1 BLISTER PACK | 1 blister pack | 2018-01-19 | 0000-00-00 | No | No | Current |