Digoxin
- Product NDC
- 0115-9822
- 11-digit product format
- 001159822
- Labeler code
- 0115
- Product ID
- 0115-9822_606fde89-1d1f-43b4-a06b-aaa36b994315
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DIGOXIN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA078556
- Marketing category
- ANDA
- Marketing start
- 2009-07-20
- Substance
- DIGOXIN
- Active strength
- 250 ug/1
- 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 | 250 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 |
|---|
| 0115-9822-01 | Digoxin | 100 in 1 BOTTLE | TABLET | 100 | | 18 |
| 0115-9822-02 | Digoxin | 500 in 1 BOTTLE | TABLET | 500 | | 18 |
| 0115-9822-03 | Digoxin | 1000 in 1 BOTTLE | TABLET | 1000 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIGOXIN | ACTIVE INGREDIENT | 73K4184T59 | DIGOXIN TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 8 | |
| DIGOXIN | ACTIVE MOIETY | 73K4184T59 | DIGOXIN TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DIGOXIN TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 8 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | DIGOXIN TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 8 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DIGOXIN TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DIGOXIN TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 8 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DIGOXIN TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 8 | |
| DIGOXIN | ACTIVE INGREDIENT | 73K4184T59 | DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| DIGOXIN | ACTIVE MOIETY | 73K4184T59 | DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-9822 | DIGOXIN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 18 | Current NDC, Legacy NDC, 3 package rows | 20240906_dfac7f13-28be-423d-9389-9089da29da17.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 |
|---|
| 0115-9822-01 | 00115982201 | 100 TABLET in 1 BOTTLE (0115-9822-01) | 100 tablet | 2009-07-20 | 0000-00-00 | No | No | Current |
| 0115-9822-02 | 00115982202 | 500 TABLET in 1 BOTTLE (0115-9822-02) | 500 tablet | 2009-07-20 | 0000-00-00 | No | No | Current |
| 0115-9822-03 | 00115982203 | 1000 TABLET in 1 BOTTLE (0115-9822-03) | 1000 tablet | 2009-07-20 | 0000-00-00 | No | No | Current |