Pradaxa
- Product NDC
- 50090-3617
- 11-digit product format
- 500903617
- Labeler code
- 50090
- Product ID
- 50090-3617_76d95065-2155-4146-b551-d96f79612da0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dabigatran etexilate mesylate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- NDA022512
- Marketing category
- NDA
- Marketing start
- 2017-07-28
- Marketing end
- 0000-00-00
- Substance
- DABIGATRAN ETEXILATE MESYLATE
- Active strength
- 150 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-3617-0 | Pradaxa | 60 in 1 BOTTLE | CAPSULE | 60 | | 8 |
| 50090-3617-0 | Pradaxa | 1 in 1 CARTON | CAPSULE | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-3617 | PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [A-S MEDICATION SOLUTIONS] | 8 | Legacy NDC, 2 package rows | 20210617_80637981-d5a7-48cb-b7b2-f50807a8ab20.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-3617-0 | 50090361700 | 1 BOTTLE in 1 CARTON (50090-3617-0) > 60 CAPSULE in 1 BOTTLE | 1 bottle | 2018-10-05 | 0000-00-00 | No | No | Current |