PRADAXA
- Product NDC
- 21695-899
- 11-digit product format
- 216950899
- Labeler code
- 21695
- Product ID
- 21695-899_5db7f199-8752-4d24-85f7-e34ca8f4d02e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dabigatran etexilate mesylate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- NDA022512
- Marketing category
- NDA
- Marketing start
- 2010-10-26
- Marketing end
- 0000-00-00
- Substance
- DABIGATRAN ETEXILATE MESYLATE
- Active strength
- 150 mg/1
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 21695-899-60 | PRADAXA | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-899 | PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 1 package rows | 20110414_5db7f199-8752-4d24-85f7-e34ca8f4d02e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-899-60 | 21695089960 | 60 in 1 BOTTLE | Historical |