Hydroxychloroquine sulfate
- Product NDC
- 57664-761
- 11-digit product format
- 576640761
- Labeler code
- 57664
- Product ID
- 57664-761_cb7adb60-886b-4415-9b04-b6d37712bbe0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxychloroquine sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA201691
- Marketing category
- ANDA
- Marketing start
- 2018-06-18
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57664-761-13 | Hydroxychloroquine sulfate | 500 in 1 BOTTLE | TABLET | 500 | | 8 |
| 57664-761-88 | Hydroxychloroquine sulfate | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57664-761 | HYDROXYCHLOROQUINE SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20221112_6e72fe06-7995-3fd7-e053-2a91aa0a54db.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57664-761-13 | 57664076113 | 500 TABLET in 1 BOTTLE (57664-761-13) | 500 tablet | 2018-06-18 | 0000-00-00 | No | No | Current |
| 57664-761-88 | 57664076188 | 100 TABLET in 1 BOTTLE (57664-761-88) | 100 tablet | 2018-06-18 | 0000-00-00 | No | No | Current |