Hydroxychloroquine Sulfate
- Product NDC
- 71610-961
- 11-digit product format
- 716100961
- Labeler code
- 71610
- Product ID
- 71610-961_427ac308-f737-d1f0-e063-6294a90ae7a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxychloroquine Sulfate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydroxychloroquine Sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROXYCHLOROQUINE SULFATE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8Q2869CNVH |
| Rxcui | 979092 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-961-30 | 71610096130 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-961-30) | 2025-10-31 | No | No | Historical |
| 71610-961-53 | 71610096153 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-961-53) | 2025-10-31 | No | No | Historical |
| 71610-961-80 | 71610096180 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-961-80) | 2025-10-31 | No | No | Historical |