Digoxin
- Product NDC
- 16714-591
- 11-digit product format
- 167140591
- Labeler code
- 16714
- Product ID
- 16714-591_b6988d7b-4a9b-4c1a-b9e1-197ef632abb3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Digoxin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northstar Rx LLC
- Application
- ANDA076363
- Marketing category
- ANDA
- Marketing start
- 2016-09-12
- Marketing end
- 0000-00-00
- Substance
- DIGOXIN
- Active strength
- 250 ug/1
- Pharmacologic classes
- Cardiac Glycoside [EPC],Cardiac Glycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 16714-591-01 | 2020-08-05 | C162847 | 48780-1 | ab0e2407-28c9-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 |
| 16714-591-01 | 2020-08-05 | C162847 | 48780-1 | ab0e2407-28c9-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 |
| 16714-591-02 | 2020-08-05 | C162847 | 48780-1 | ab0e2407-28c9-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 |
| 16714-591-02 | 2020-08-05 | C162847 | 48780-1 | ab0e2407-28c9-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 |
| 16714-591-01 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-28c9-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 |
| 16714-591-01 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-28c9-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 |
| 16714-591-02 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-28c9-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 |
| 16714-591-02 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-28c9-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-591 | DIGOXIN TABLET [NORTHSTAR RX LLC] | 8 | Legacy NDC | 20240627_8ec4abe0-7974-4921-b542-c9673dc5f77f.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 |
|---|
| 16714-591-01 | 16714059101 | 100 TABLET in 1 BOTTLE (16714-591-01) | 100 tablet | 2016-09-12 | 0000-00-00 | No | No | Current |
| 16714-591-02 | 16714059102 | 1000 TABLET in 1 BOTTLE (16714-591-02) | 1000 tablet | 2016-09-12 | 0000-00-00 | No | No | Current |