Digoxin
- Product NDC
- 82685-201
- 11-digit product format
- 826850201
- Labeler code
- 82685
- Product ID
- 82685-201_48481a34-0b24-a796-e063-6294a90af307
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Digoxin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Oliva Therapeutics, LLC
- Application
- ANDA076268
- Marketing category
- ANDA
- Marketing start
- 2022-09-01
- Substance
- DIGOXIN
- Active strength
- 125 ug/1
- Pharmacologic classes
- Cardiac Glycoside [EPC], Cardiac Glycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Digoxin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIGOXIN | 125 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 73K4184T59 |
| Rxcui | 197604, 197606 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82685-201-01 | Digoxin | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
| 82685-201-10 | Digoxin | 1000 in 1 BOTTLE | TABLET | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82685-201 | DIGOXIN TABLET [OLIVA THERAPEUTICS, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230630_5b2d10d0-6e9d-4c39-a025-6b2f30ff6243.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 |
|---|
| 82685-201-01 | 82685020101 | 100 TABLET in 1 BOTTLE (82685-201-01) | 100 tablet | 2022-09-01 | 0000-00-00 | No | No | Current |
| 82685-201-10 | 82685020110 | 1000 TABLET in 1 BOTTLE (82685-201-10) | 1000 tablet | 2022-09-01 | 0000-00-00 | No | No | Current |