Hydroxychloroquine Sulfate
- Product NDC
- 0591-3041
- 11-digit product format
- 005913041
- Labeler code
- 0591
- Product ID
- 0591-3041_13086805-6932-4286-88b3-baadb6123662
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxychloroquine Sulfate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA040133
- Marketing category
- ANDA
- Marketing start
- 2016-03-30
- Marketing end
- 2022-03-31
- Substance
- HYDROXYCHLOROQUINE SULFATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Antimalarial [EPC], Antirheumatic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 476a7bfa-95aa-4caa-a32b-b0e157b2cc83 | Product name | 1 | 20220928 |
| 79a2ab33-ef76-b1c3-49e7-8533315e153b | Product name | 5 | 20200716 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0591-3041-01 | 2020-09-30 | C162847 | 48780-1 | ab0e2407-2fb1-f274-e053-dbdaa90a6471 | 5f5f1dee-854a-41f6-b304-d7fdf8dd3ea0 |
| 0591-3041-05 | 2020-09-30 | C162847 | 48780-1 | ab0e2407-2fb1-f274-e053-dbdaa90a6471 | 5f5f1dee-854a-41f6-b304-d7fdf8dd3ea0 |
| 0591-3041-01 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-2fb1-f274-e053-dbdaa90a6471 | 5f5f1dee-854a-41f6-b304-d7fdf8dd3ea0 |
| 0591-3041-05 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-2fb1-f274-e053-dbdaa90a6471 | 5f5f1dee-854a-41f6-b304-d7fdf8dd3ea0 |
| 0591-3041-01 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-2fb1-f274-e053-dbdaa90a6471 | 5f5f1dee-854a-41f6-b304-d7fdf8dd3ea0 |
| 0591-3041-05 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-2fb1-f274-e053-dbdaa90a6471 | 5f5f1dee-854a-41f6-b304-d7fdf8dd3ea0 |
| 0591-3041-01 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2fb1-f274-e053-dbdaa90a6471 | 5f5f1dee-854a-41f6-b304-d7fdf8dd3ea0 |
| 0591-3041-05 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2fb1-f274-e053-dbdaa90a6471 | 5f5f1dee-854a-41f6-b304-d7fdf8dd3ea0 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 979092 | hydroxychloroquine sulfate 200 MG Oral Tablet | PSN | 9c1abafe-e99f-4c09-aa43-0b60867fdcdb | 14 |
| 979092 | hydroxychloroquine sulfate 200 MG Oral Tablet | SCD | 9c1abafe-e99f-4c09-aa43-0b60867fdcdb | 14 |
| 979092 | hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet | SY | 9c1abafe-e99f-4c09-aa43-0b60867fdcdb | 14 |
| 979092 | hydroxychloroquine sulfate 200 MG Oral Tablet | PSN | 1b49a98f-37a8-4b01-8a82-90b947bbc223 | 3 |
| 979092 | hydroxychloroquine sulfate 200 MG Oral Tablet | SCD | 1b49a98f-37a8-4b01-8a82-90b947bbc223 | 3 |
| 979092 | hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet | SY | 1b49a98f-37a8-4b01-8a82-90b947bbc223 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0591-3041-01 | 00591304101 | 100 TABLET, FILM COATED in 1 BOTTLE (0591-3041-01) | 2016-03-30 | 2022-03-31 | No | No | Current |
| 0591-3041-05 | 00591304105 | 500 TABLET, FILM COATED in 1 BOTTLE (0591-3041-05) | 2016-03-30 | 2021-09-30 | No | No | Current |