HYDROXYCHLOROQUINE SULFATE
- Product NDC
- 82619-131
- 11-digit product format
- 826190131
- Labeler code
- 82619
- Product ID
- 82619-131_40b93dff-c062-433c-e063-6294a90a6b67
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxychloroquine sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Creekwood Pharmaceuticals LLC
- Application
- ANDA040150
- Marketing category
- ANDA
- Marketing start
- 2025-05-08
- Substance
- HYDROXYCHLOROQUINE SULFATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Antimalarial [EPC], Antirheumatic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040150-001 | HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1996-01-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040150-001 | 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 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1996-01-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1996-01-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1996-01-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1996-01-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1996-01-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1996-01-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1996-01-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1996-01-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1996-01-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1996-01-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1996-01-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1996-01-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1996-01-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | AB | 1996-01-27 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040150-001 | HYDROXYCHLOROQUINE SULFATE | 200MG | TABLET / ORAL | 1996-01-27 | 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 | A040150-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040150-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040150-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040150-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040150-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040150-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040150-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040150-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040150-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040150-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040150-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040150-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040150-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040150-001 | AB | 1 | 8072bd15b7f6… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A040150-001 | AB | 1 | a50c72e98297… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HYDROXYCHLOROQUINE SULFATE
- Listing expiration
- 2026-12-31
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 |
|---|---|
| 04139607-f7c0-4fe1-a210-ffa5af347d56 | Available on FDA.report |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82619-131-01 | HYDROXYCHLOROQUINE SULFATE | 100 in 1 BOTTLE | TABLET | 100 | 3 | |
| 82619-131-02 | HYDROXYCHLOROQUINE SULFATE | 500 in 1 BOTTLE | TABLET | 500 | 3 | |
| 82619-131-03 | HYDROXYCHLOROQUINE SULFATE | 1000 in 1 BOTTLE | TABLET | 1000 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 82619-131-01 | EA - Each | 82619-131 | 21bb6fb6-9bdf-4bda-912c-05a3c3c907cd | 1 | 2025-08-11 |
| 82619-131-02 | EA - Each | 82619-131 | 0b12c723-33bf-4c2d-ab9c-f7cb3085b212 | 1 | 2025-08-11 |
DailyMed Dashboard NDC Coverage#
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 | 68d6439d-b927-47e6-86ef-20e572e81941 | 2026-06-08 | Warnings, Adverse reactions | 040150 ANDA040150 |
| HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Bryant Ranch Prepack | 1a39c45e-dc14-4441-9b02-7329647bc5a4 | 2026-03-30 | Warnings, Adverse reactions | 040150 ANDA040150 |
| HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Bryant Ranch Prepack | 517ee47b-6abf-43cb-a4ca-c2e7827461a8 | 2026-03-16 | Warnings, Adverse reactions | 040150 ANDA040150 |
| HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Creekwood Pharmaceuticals LLC | 04139607-f7c0-4fe1-a210-ffa5af347d56 | 2025-10-09 | Warnings, Adverse reactions | 040150 ANDA040150 82619-131 |
| HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Bryant Ranch Prepack | f95cfc03-5023-44b3-8994-25afac18b734 | 2025-10-02 | Warnings, Adverse reactions | 040150 ANDA040150 |
| HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | Bryant Ranch Prepack | 84957919-ca14-4c3d-b4fe-452ff330dd7a | 2025-10-02 | Warnings, Adverse reactions | 040150 ANDA040150 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 979092 | hydroxychloroquine sulfate 200 MG Oral Tablet | PSN | 517ee47b-6abf-43cb-a4ca-c2e7827461a8 | 102 |
| 979092 | hydroxychloroquine sulfate 200 MG Oral Tablet | SCD | 517ee47b-6abf-43cb-a4ca-c2e7827461a8 | 102 |
| 979092 | hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet | SY | 517ee47b-6abf-43cb-a4ca-c2e7827461a8 | 102 |
| 979092 | hydroxychloroquine sulfate 200 MG Oral Tablet | PSN | 04139607-f7c0-4fe1-a210-ffa5af347d56 | 3 |
| 979092 | hydroxychloroquine sulfate 200 MG Oral Tablet | SCD | 04139607-f7c0-4fe1-a210-ffa5af347d56 | 3 |
| 979092 | hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet | SY | 04139607-f7c0-4fe1-a210-ffa5af347d56 | 3 |
| 979092 | hydroxychloroquine sulfate 200 MG Oral Tablet | PSN | 1a39c45e-dc14-4441-9b02-7329647bc5a4 | 1 |
| 979092 | hydroxychloroquine sulfate 200 MG Oral Tablet | PSN | 84957919-ca14-4c3d-b4fe-452ff330dd7a | 1 |
| 979092 | hydroxychloroquine sulfate 200 MG Oral Tablet | PSN | f95cfc03-5023-44b3-8994-25afac18b734 | 1 |
| 979092 | hydroxychloroquine sulfate 200 MG Oral Tablet | SCD | 1a39c45e-dc14-4441-9b02-7329647bc5a4 | 1 |
| 979092 | hydroxychloroquine sulfate 200 MG Oral Tablet | SCD | 84957919-ca14-4c3d-b4fe-452ff330dd7a | 1 |
| 979092 | hydroxychloroquine sulfate 200 MG Oral Tablet | SCD | f95cfc03-5023-44b3-8994-25afac18b734 | 1 |
| 979092 | hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet | SY | 1a39c45e-dc14-4441-9b02-7329647bc5a4 | 1 |
| 979092 | hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet | SY | 84957919-ca14-4c3d-b4fe-452ff330dd7a | 1 |
| 979092 | hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet | SY | f95cfc03-5023-44b3-8994-25afac18b734 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 82619-131-01 | 82619013101 | 100 TABLET in 1 BOTTLE (82619-131-01) | 100 tablet | 2025-05-08 | No | No | Current |
| 82619-131-02 | 82619013102 | 500 TABLET in 1 BOTTLE (82619-131-02) | 500 tablet | 2025-05-08 | No | No | Current |
| 82619-131-03 | 82619013103 | 1000 TABLET in 1 BOTTLE (82619-131-03) | 1000 tablet | 2025-05-08 | No | No | Current |