Plaquenil
- Product NDC
- 43353-997
- 11-digit product format
- 433530997
- Labeler code
- 43353
- Product ID
- 43353-997_7fda39a8-57ef-42fa-8eda-03f88eb0c7ce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxychloroquine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA009768
- Marketing category
- NDA
- Marketing start
- 2013-06-28
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43353-997-09 | 2020-04-02 | C162847 | 48780-1 | a2593519-545e-223c-e053-dbdaa90af026 | 53355f8f-e3bb-4db1-8e11-e721c5b62067 |
| 43353-997-53 | 2020-04-02 | C162847 | 48780-1 | a2593519-545e-223c-e053-dbdaa90af026 | 53355f8f-e3bb-4db1-8e11-e721c5b62067 |
| 43353-997-60 | 2020-04-02 | C162847 | 48780-1 | a2593519-545e-223c-e053-dbdaa90af026 | 53355f8f-e3bb-4db1-8e11-e721c5b62067 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43353-997-09 | EA - Each | 43353-997 | 0597dfcf-08b4-42dd-aff2-30981ca157d1 | 1 | 2016-07-19 |
| 43353-997-53 | EA - Each | 43353-997 | 60403ecc-df05-4ab1-9f88-87f1f170afd2 | 1 | 2016-07-19 |
| 43353-997-60 | EA - Each | 43353-997 | e6035f2b-e223-48a0-a457-3f8b38b9297b | 1 | 2016-07-19 |