Hydroxychloroquine Sulfate
- Product NDC
- 43353-103
- 11-digit product format
- 433530103
- Labeler code
- 43353
- Product ID
- 43353-103_5455d995-4fff-448f-8743-6e7bee209371
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxychloroquine Sulfate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA040104
- Marketing category
- ANDA
- Marketing start
- 1995-11-30
- 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 |
|---|---|---|---|---|---|
| 43353-103-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6cdc-f424-e053-dadaa90a57ce | 9fbb5249-0291-4034-93b4-b13ff647e9c9 |
| 43353-103-53 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6cdc-f424-e053-dadaa90a57ce | 9fbb5249-0291-4034-93b4-b13ff647e9c9 |
| 43353-103-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6cdc-f424-e053-dadaa90a57ce | 9fbb5249-0291-4034-93b4-b13ff647e9c9 |
| 43353-103-80 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6cdc-f424-e053-dadaa90a57ce | 9fbb5249-0291-4034-93b4-b13ff647e9c9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43353-103-09 | EA - Each | 43353-103 | 83ddb7a7-0ca1-460e-802d-46698069f29c | 1 | 2016-07-19 |
| 43353-103-53 | EA - Each | 43353-103 | 7278bbe4-31be-4653-b487-75af22deab0e | 1 | 2016-07-19 |
| 43353-103-60 | EA - Each | 43353-103 | 319637d1-a0e2-4566-b419-789e8099a2c1 | 1 | 2016-07-19 |
| 43353-103-80 | EA - Each | 43353-103 | 36055a02-d32a-49f7-8acd-e4bf887f688d | 1 | 2016-07-19 |