SOVUNA
- Product NDC
- 70954-804
- 11-digit product format
- 709540804
- Labeler code
- 70954
- Product ID
- 70954-804_f8c163b7-15a0-424d-b53d-05fb400948bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxychloroquine Sulfate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- NDA214581
- Marketing category
- NDA
- Marketing start
- 2023-09-15
- 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
- SOVUNA
- 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, 2569283, 2665282, 2665284 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-804-10 | SOVUNA | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 70954-804-20 | SOVUNA | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
| 70954-804-30 | SOVUNA | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-804 | SOVUNA (HYDROXYCHLOROQUINE SULFATE) TABLET, FILM COATED [ANI PHARMACEUTICALS, INC.] | 4 | Current NDC, 3 package rows | 20250131_dd441154-b196-4d4c-bc56-2e37f345ef8d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70954-804-10 | 70954080410 | 30 TABLET, FILM COATED in 1 BOTTLE (70954-804-10) | 2023-09-15 | No | No | Current |
| 70954-804-20 | 70954080420 | 100 TABLET, FILM COATED in 1 BOTTLE (70954-804-20) | 2023-09-15 | No | No | Current |
| 70954-804-30 | 70954080430 | 14 TABLET, FILM COATED in 1 BOTTLE (70954-804-30) | 2023-09-15 | Yes | No | Current |