Sotalol Hydrochloride
- Product NDC
- 71610-074
- 11-digit product format
- 716100074
- Labeler code
- 71610
- Product ID
- 71610-074_0e87b445-6112-4dfa-9961-95beb8f7eb82
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sotalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076214
- Marketing category
- ANDA
- Marketing start
- 2003-09-09
- Substance
- SOTALOL HYDROCHLORIDE
- Active strength
- 80 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sotalol Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SOTALOL HYDROCHLORIDE | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HEC37C70XX |
| Rxcui | 1922765 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-074-30 | Sotalol Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 1 |
| 71610-074-60 | Sotalol Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-074 | SOTALOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20180713_5ede17b7-3898-4f9f-abec-e15620cef76a.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 |
|---|
| 71610-074-30 | 71610007430 | 30 TABLET in 1 BOTTLE, PLASTIC (71610-074-30) | 30 tablet | 2018-05-21 | 0000-00-00 | No | No | Current |
| 71610-074-60 | 71610007460 | 90 TABLET in 1 BOTTLE, PLASTIC (71610-074-60) | 90 tablet | 2018-05-21 | 0000-00-00 | No | No | Current |