Hydroxychloroquine Sulfate
- Product NDC
- 43353-794
- 11-digit product format
- 433530794
- Labeler code
- 43353
- Product ID
- 43353-794_fa4f2400-1f0e-402b-a511-b791ad6ab78e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxychloroquine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA040133
- Marketing category
- ANDA
- Marketing start
- 2012-02-29
- Marketing end
- 0000-00-00
- Substance
- HYDROXYCHLOROQUINE SULFATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Antirheumatic Agent [EPC],Antimalarial [EPC]
- 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 |
|---|---|---|---|---|---|
| 43353-794-16 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-efba-f424-e053-dadaa90a57ce | 8a99dbe0-2055-4513-b182-0416ceecd5f1 |
| 43353-794-53 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-efba-f424-e053-dadaa90a57ce | 8a99dbe0-2055-4513-b182-0416ceecd5f1 |
| 43353-794-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-efba-f424-e053-dadaa90a57ce | 8a99dbe0-2055-4513-b182-0416ceecd5f1 |
| 43353-794-80 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-efba-f424-e053-dadaa90a57ce | 8a99dbe0-2055-4513-b182-0416ceecd5f1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43353-794-53 | EA - Each | 43353-794 | 4f17edfd-4050-4086-a143-ccbbb8538dc4 | 1 | 2014-07-02 |
| 43353-794-60 | EA - Each | 43353-794 | 32cc8d0e-911b-4deb-ab9a-d35817082544 | 1 | 2014-07-02 |
| 43353-794-80 | EA - Each | 43353-794 | 5fa2140c-9a81-4542-92a8-0939970a03c1 | 1 | 2014-07-02 |