Hydroxychloroquine sulfate
- Product NDC
- 68382-096
- 11-digit product format
- 683820096
- Labeler code
- 68382
- Product ID
- 68382-096_8b9ea8e4-c27b-4b81-b8d0-2d5eddcec21a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxychloroquine sulfate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA040657
- Marketing category
- ANDA
- Marketing start
- 2008-01-03
- 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 |
|---|
| 68382-096-01 | Hydroxychloroquine sulfate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 11 |
| 68382-096-05 | Hydroxychloroquine sulfate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 11 |
| 68382-096-30 | Hydroxychloroquine sulfate | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 11 |
| 68382-096-77 | Hydroxychloroquine sulfate | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROXYCHLOROQUINE SULFATE | ACTIVE INGREDIENT | 8Q2869CNVH | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| HYDROXYCHLOROQUINE | ACTIVE MOIETY | 4QWG6N8QKH | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| HYDROXYCHLOROQUINE SULFATE | ACTIVE INGREDIENT | 8Q2869CNVH | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| HYDROXYCHLOROQUINE | ACTIVE MOIETY | 4QWG6N8QKH | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-096 | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] | 11 | Current NDC, Legacy NDC, 4 package rows | 20231222_805a1acd-2e0d-48f1-af6b-0e5d8e06c228.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 |
|---|
| 68382-096-01 | 68382009601 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-096-01) | | 2008-01-03 | 0000-00-00 | No | No | Current |
| 68382-096-05 | 68382009605 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-096-05) | | 2008-01-03 | 0000-00-00 | No | No | Current |
| 68382-096-30 | 68382009630 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 68382-096-77 | 68382009677 | 100 BLISTER PACK in 1 CARTON (68382-096-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-096-30) | 100 blister pack | 2008-01-03 | 0000-00-00 | No | No | Current |