Digoxin
- Product NDC
- 50436-0324
- 11-digit product format
- 504360324
- Labeler code
- 50436
- Product ID
- 50436-0324_f1c44f48-8681-41b4-b7d4-ed95adf48249
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Digoxin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA076268
- Marketing category
- ANDA
- Marketing start
- 2002-07-26
- Marketing end
- 0000-00-00
- Substance
- DIGOXIN
- Active strength
- 125 ug/1
- Pharmacologic classes
- Cardiac Glycoside [EPC],Cardiac Glycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 20d84de3-cb46-44c4-9211-63e833fa2688 | Product name | 2 | 20221214 |
| 4d74103a-bb9b-9034-fbc8-dac635e6e729 | Product name | 3 | 20221117 |
| 5c3aa978-6f46-c7ca-2a83-b57385976bee | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-0324-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-17d8-a910-e053-dadaa90a0b85 | Digoxin Tablets, USP 125 mcg (0.125 mg) 250 mcg (0.25 mg) |
| 50436-0324-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-17d8-a910-e053-dadaa90a0b85 | Digoxin Tablets, USP 125 mcg (0.125 mg) 250 mcg (0.25 mg) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-0324-2 | Digoxin | 30 in 1 BOTTLE | TABLET | 30 | 12 | |
| 50436-0324-3 | Digoxin | 90 in 1 BOTTLE | TABLET | 90 | 12 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| DIGOXIN | ACTIVE INGREDIENT | 73K4184T59 | DIGOX (DIGOXIN) TABLET [UNIT DOSE SERVICES] | 2 | |
| DIGOXIN | ACTIVE MOIETY | 73K4184T59 | DIGOX (DIGOXIN) TABLET [UNIT DOSE SERVICES] | 2 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | DIGOX (DIGOXIN) TABLET [UNIT DOSE SERVICES] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DIGOX (DIGOXIN) TABLET [UNIT DOSE SERVICES] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | DIGOX (DIGOXIN) TABLET [UNIT DOSE SERVICES] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DIGOX (DIGOXIN) TABLET [UNIT DOSE SERVICES] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DIGOX (DIGOXIN) TABLET [UNIT DOSE SERVICES] | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | DIGOX (DIGOXIN) TABLET [UNIT DOSE SERVICES] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-0324 | DIGOXIN TABLET [UNIT DOSE SERVICES] | 12 | Legacy NDC, 2 package rows | 20160531_d2b7a781-8ef2-482b-b359-ef47d12f3e8e.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197604 | digoxin 125 MCG Oral Tablet | PSN | d2b7a781-8ef2-482b-b359-ef47d12f3e8e | 12 |
| 197604 | digoxin 0.125 MG Oral Tablet | SCD | d2b7a781-8ef2-482b-b359-ef47d12f3e8e | 12 |
| 197604 | digoxin 125 MCG Oral Tablet | SY | d2b7a781-8ef2-482b-b359-ef47d12f3e8e | 12 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-0324-2 | 50436032402 | 30 in 1 BOTTLE | Historical |
| 50436-0324-3 | 50436032403 | 90 in 1 BOTTLE | Historical |