Pradaxa
- Product NDC
- 63629-8242
- 11-digit product format
- 636298242
- Labeler code
- 63629
- Product ID
- 63629-8242_1a214cf1-b41e-46f6-8f24-e3637e6d2612
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dabigatran etexilate mesylate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- NDA022512
- Marketing category
- NDA
- Marketing start
- 2017-07-28
- Marketing end
- 0000-00-00
- Substance
- DABIGATRAN ETEXILATE MESYLATE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8242 | PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [BRYANT RANCH PREPACK] | 3 | Legacy NDC | 20240511_1a214cf1-b41e-46f6-8f24-e3637e6d2612.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8242-1 | 63629824201 | 30 CAPSULE in 1 BOTTLE (63629-8242-1) | 30 capsule | 2019-09-10 | 0000-00-00 | No | No | Current |