Pradaxa
- Product NDC
- 0597-0135
- 11-digit product format
- 005970135
- Labeler code
- 0597
- Product ID
- 0597-0135_fa979d2d-b271-4c7e-8afa-d04f9dea331e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dabigatran etexilate mesylate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Boehringer Ingelheim Pharmaceuticals Inc.
- Application
- NDA022512
- Marketing category
- NDA
- Marketing start
- 2010-10-26
- Marketing end
- 2020-05-31
- Substance
- DABIGATRAN ETEXILATE MESYLATE
- Active strength
- 150 mg/1
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0597-0135-54 | EA - Each | 0597-0135 | e22a5a70-7242-4e0e-bb05-ad0a10eaa3be | 1 | 2012-07-24 |
| 0597-0135-60 | EA - Each | 0597-0135 | c7b6f188-d226-41bf-afb4-a017efa2a802 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1037045 | dabigatran etexilate 150 MG Oral Capsule | PSN | 5db7f199-8752-4d24-85f7-e34ca8f4d02e | 1 |
| 1037049 | Pradaxa 150 MG Oral Capsule | PSN | 5db7f199-8752-4d24-85f7-e34ca8f4d02e | 1 |
| 1037049 | dabigatran etexilate 150 MG Oral Capsule [Pradaxa] | SBD | 5db7f199-8752-4d24-85f7-e34ca8f4d02e | 1 |
| 1037045 | dabigatran etexilate 150 MG Oral Capsule | SCD | 5db7f199-8752-4d24-85f7-e34ca8f4d02e | 1 |
| 1037045 | dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral Capsule | SY | 5db7f199-8752-4d24-85f7-e34ca8f4d02e | 1 |
| 1037049 | Pradaxa 150 MG (as dabigatran etexilate mesylate 172.95 MG) Oral Capsule | SY | 5db7f199-8752-4d24-85f7-e34ca8f4d02e | 1 |
| 1037049 | Pradaxa 150 MG Oral Capsule | SY | 5db7f199-8752-4d24-85f7-e34ca8f4d02e | 1 |