Hydroxychloroquine sulfate
- Product NDC
- 76420-850
- 11-digit product format
- 764200850
- Labeler code
- 76420
- Product ID
- 76420-850_21587ffd-a2a5-f093-e063-6394a90a6658
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxychloroquine sulfate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA040657
- Marketing category
- ANDA
- Marketing start
- 2019-10-01
- 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 |
|---|
| 76420-850-01 | Hydroxychloroquine sulfate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 76420-850-05 | Hydroxychloroquine sulfate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
| 76420-850-30 | Hydroxychloroquine sulfate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 76420-850-60 | Hydroxychloroquine sulfate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 76420-850-90 | Hydroxychloroquine sulfate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-850 | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [ASCLEMED USA, INC.] | 1 | Current NDC, 5 package rows | 20240907_19816051-c25e-44b5-a127-e846dbd0a8d8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-850-01 | 76420085001 | 100 TABLET, FILM COATED in 1 BOTTLE (76420-850-01) | 2024-09-05 | No | No | Current |
| 76420-850-05 | 76420085005 | 500 TABLET, FILM COATED in 1 BOTTLE (76420-850-05) | 2024-09-05 | No | No | Current |
| 76420-850-30 | 76420085030 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-850-30) | 2024-09-05 | No | No | Current |
| 76420-850-60 | 76420085060 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-850-60) | 2024-09-05 | No | No | Current |
| 76420-850-90 | 76420085090 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-850-90) | 2024-09-05 | No | No | Current |