Pradaxa
- Product NDC
- 50090-4480
- 11-digit product format
- 500904480
- Labeler code
- 50090
- Product ID
- 50090-4480_6ca37acc-f0e5-4ea7-ba56-938bf43dd0cb
- 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
- 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-4480-0 | 50090448000 | 1 BOTTLE in 1 CARTON (50090-4480-0) > 60 CAPSULE in 1 BOTTLE | 1 bottle | 2019-08-28 | 0000-00-00 | No | No | Current |