HYDROXYCHLOROQUINE SULFATE
- Product NDC
- 43598-131
- 11-digit product format
- 435980131
- Labeler code
- 43598
- Product ID
- 43598-131_45c22bbf-6332-4f7f-b77e-8ac613435821
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROXYCHLOROQUINE SULFATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA210441
- Marketing category
- ANDA
- Marketing start
- 2022-10-24
- Substance
- HYDROXYCHLOROQUINE SULFATE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Antimalarial [EPC], Antirheumatic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 8Q2869CNVH | HYDROXYCHLOROQUINE SULFATE | 747-36-4 | HYDROXYCHLOROQUINE SULFATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 43598-131-01 | 43598013101 | 100 TABLET, FILM COATED in 1 BOTTLE (43598-131-01) | 2022-10-24 | No | No | Historical |
| 43598-131-05 | 43598013105 | 500 TABLET, FILM COATED in 1 BOTTLE (43598-131-05) | 2022-10-24 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| HYDROXYCHLOROQUINE SULFATE | Dr. Reddy's Laboratories Inc. | Appco Pharma LLC | Axxelent Pharma | 2025-12-05 | Human Prescription Drug Label | 17 |
| HYDROXYCHLOROQUINE SULFATE | Dr. Reddy's Laboratories Inc. | Appco Pharma LLC | 2024-06-12 | Human Prescription Drug Label | 15 |