Digoxin
- Product NDC
- 0054-0057
- 11-digit product format
- 000540057
- Labeler code
- 0054
- Product ID
- 0054-0057_db501397-8e41-4498-8626-49c6bfd79971
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Digoxin
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA021648
- Marketing category
- NDA
- Marketing start
- 2004-08-26
- Substance
- DIGOXIN
- Active strength
- .05 mg/mL
- Pharmacologic classes
- Cardiac Glycoside [EPC], Cardiac Glycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Digoxin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIGOXIN | .05 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 73K4184T59 |
| Rxcui | 393245 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0057-46 | Digoxin | 60 mL in 1 BOTTLE | SOLUTION | 60 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIGOXIN | ACTIVE INGREDIENT | 73K4184T59 | DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] | 10 | |
| DIGOXIN | ACTIVE MOIETY | 73K4184T59 | DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] | 10 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] | 10 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] | 10 | |
| LIME (CITRUS) | INACTIVE INGREDIENT | 8CZS546954 | DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] | 10 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] | 10 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] | 10 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] | 10 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] | 10 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] | 10 | |
| DIGOXIN | ACTIVE INGREDIENT | 73K4184T59 | DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 6 | |
| DIGOXIN | ACTIVE MOIETY | 73K4184T59 | DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 6 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 6 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 6 | |
| LIME (CITRUS) | INACTIVE INGREDIENT | 8CZS546954 | DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 6 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 6 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 6 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 6 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0057 | DIGOXIN SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 18 | Current NDC, Legacy NDC, 1 package rows | 20250418_1b7e5c6e-e052-41b0-a4ce-05dfe62faaaf.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 |
|---|
| 0054-0057-46 | 00054005746 | 60 mL in 1 BOTTLE (0054-0057-46) | 60 ml | 2004-08-26 | 0000-00-00 | No | No | Current |