Hydroxychloroquine Sulfate
- Product NDC
- 50090-4659
- Requested package NDC
- 50090-4659-3
- 11-digit product format
- 500904659
- Labeler code
- 50090
- Product ID
- 50090-4659_755581f8-6167-46af-991f-9cb92a16d06c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxychloroquine Sulfate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA210577
- Marketing category
- ANDA
- Marketing start
- 2018-05-17
- Substance
- HYDROXYCHLOROQUINE SULFATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Antimalarial [EPC], Antirheumatic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-4659 | 50090-4659-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-4659 | 50090-4659-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210577-001 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210577-001 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A210577-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 2018-05-15 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210577-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210577-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210577-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210577-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210577-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210577-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210577-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210577-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210577-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210577-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210577-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210577-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210577-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210577-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210577-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A210577-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A210577-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A210577-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A210577-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A210577-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210577-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A210577-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A210577-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A210577-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A210577-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A210577-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A210577-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210577-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A210577-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A210577-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210577-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210577-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210577-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210577-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A210577-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A210577-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210577-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A210577-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A210577-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A210577-001 | AB | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydroxychloroquine Sulfate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROXYCHLOROQUINE SULFATE | 200 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8Q2869CNVH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 979092 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 87076a61-ce76-475b-ac6d-c33ba617195d | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 476a7bfa-95aa-4caa-a32b-b0e157b2cc83 | Product name | 1 | 20220928 |
| 79a2ab33-ef76-b1c3-49e7-8533315e153b | Product name | 5 | 20200716 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-4659-1 | Hydroxychloroquine Sulfate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 12 | |
| 50090-4659-2 | Hydroxychloroquine Sulfate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 12 | |
| 50090-4659-3 | Hydroxychloroquine Sulfate | 12 in 1 BOTTLE | TABLET, FILM COATED | 12 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-4659-1 | EA - Each | 50090-4659 | 09bbf6cf-74ff-4b72-a93b-bd4583c0d4a4 | 1 | 2022-12-07 |
| 50090-4659-2 | EA - Each | 50090-4659 | 7a46102e-9d51-4551-8fc9-bc587de09cc2 | 1 | 2022-12-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-4659 | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 10 | Current NDC, Legacy NDC, 3 package rows | 20250430_87076a61-ce76-475b-ac6d-c33ba617195d.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hydroxychloroquine Sulfate | HYDROXYCHLOROQUINE SULFATE | Bryant Ranch Prepack | da435181-0c5a-4188-8d59-51234116b005 | 2026-06-29 | Warnings, Adverse reactions | 210577 ANDA210577 |
| Hydroxychloroquine Sulfate | HYDROXYCHLOROQUINE SULFATE | A-S Medication Solutions | 87076a61-ce76-475b-ac6d-c33ba617195d | 2026-02-14 | Warnings, Adverse reactions | 210577 ANDA210577 50090-4659-3 50090-4659 50090465903 |
| Hydroxychloroquine Sulfate | HYDROXYCHLOROQUINE SULFATE | Amneal Pharmaceuticals NY LLC | 7804f5d2-41a6-4523-a277-6967e984e88e | 2025-12-22 | Warnings, Adverse reactions | 210577 ANDA210577 |
| Hydroxychloroquine Sulfate | HYDROXYCHLOROQUINE SULFATE | Aphena Pharma Solutions - Tennessee, LLC | 427ac2fc-8f7f-9725-e063-6394a90a381b | 2025-10-31 | Warnings, Adverse reactions | 210577 ANDA210577 |
| Hydroxychloroquine Sulfate | HYDROXYCHLOROQUINE SULFATE | Amneal Pharmaceuticals NY LLC | 6a9e2fc8-bedf-46d4-9973-328dbcb18061 | 2024-06-11 | Warnings, Adverse reactions | 210577 ANDA210577 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 979092 | hydroxychloroquine sulfate 200 MG Oral Tablet | PSN | 87076a61-ce76-475b-ac6d-c33ba617195d | 12 |
| 979092 | hydroxychloroquine sulfate 200 MG Oral Tablet | SCD | 87076a61-ce76-475b-ac6d-c33ba617195d | 12 |
| 979092 | hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet | SY | 87076a61-ce76-475b-ac6d-c33ba617195d | 12 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-4659-3 | 50090465903 | 12 TABLET, FILM COATED in 1 BOTTLE (50090-4659-3) | 2020-03-17 | 0000-00-00 | No | No | Current |