sotalol hydrochloride
- Product NDC
- 0185-0174
- 11-digit product format
- 001850174
- Labeler code
- 0185
- Product ID
- 0185-0174_401b80f7-8916-4421-be5f-e0647f553c88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sotalol hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Eon Labs, Inc.
- Application
- ANDA075366
- Marketing category
- ANDA
- Marketing start
- 2000-05-01
- Marketing end
- 0000-00-00
- Substance
- SOTALOL HYDROCHLORIDE
- Active strength
- 240 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0185-0174-01 | 2020-12-02 | C162847 | 48780-1 | 9d75b9d0-2b84-f424-e053-dadaa90a57ce | 84562767-c0b0-4a59-a2ed-ea3874176af5 |
| 0185-0174-05 | 2020-12-02 | C162847 | 48780-1 | 9d75b9d0-2b84-f424-e053-dadaa90a57ce | 84562767-c0b0-4a59-a2ed-ea3874176af5 |
| 0185-0174-09 | 2020-12-02 | C162847 | 48780-1 | 9d75b9d0-2b84-f424-e053-dadaa90a57ce | 84562767-c0b0-4a59-a2ed-ea3874176af5 |
| 0185-0174-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2b84-f424-e053-dadaa90a57ce | 84562767-c0b0-4a59-a2ed-ea3874176af5 |
| 0185-0174-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2b84-f424-e053-dadaa90a57ce | 84562767-c0b0-4a59-a2ed-ea3874176af5 |
| 0185-0174-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2b84-f424-e053-dadaa90a57ce | 84562767-c0b0-4a59-a2ed-ea3874176af5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0185-0174-01 | EA - Each | 0185-0174 | 4789c61c-5f9e-4537-873b-282a6ee9a40b | 1 | 2012-07-24 |
| 0185-0174-09 | EA - Each | 0185-0174 | c6a03826-05e3-4c5b-899e-ab39424e8949 | 1 | 2012-07-24 |