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NDC 16729-0563-01 Hydroxychloroquine Sulfate 400 mg/1 Details
Hydroxychloroquine Sulfate 400 mg/1
Hydroxychloroquine Sulfate is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Accord Healthcare, Inc.,. The primary component is HYDROXYCHLOROQUINE SULFATE.
MedlinePlus Drug Summary
Hydroxychloroquine is used to prevent and treat acute attacks of malaria. It is also used to treat discoid lupus erythematosus (DLE; a chronic inflammatory condition of the skin) or systemic lupus erythematosus (SLE; a chronic inflammatory condition of the body) and rheumatoid arthritis in patients whose symptoms have not improved with other treatments. Hydroxychloroquine is in a class of drugs called antimalarials. It works by killing the organisms that cause malaria. Hydroxychloroquine may work to treat rheumatoid arthritis and systemic lupus erythematosus by decreasing the activity of the immune system.
Related Packages: 16729-0563-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydroxychloroquine
Product Information
| NDC | 16729-0563 |
|---|---|
| Product ID | 16729-563_f6f73d4a-d833-f495-e053-6294a90a99f6 |
| Associated GPIs | 13000020100310 |
| GCN Sequence Number | 047544 |
| GCN Sequence Number Description | hydroxychloroquine sulfate TABLET 400 MG ORAL |
| HIC3 | W4A |
| HIC3 Description | ANTIMALARIAL DRUGS |
| GCN | 12904 |
| HICL Sequence Number | 004151 |
| HICL Sequence Number Description | HYDROXYCHLOROQUINE SULFATE |
| Brand/Generic | Generic |
| Proprietary Name | Hydroxychloroquine Sulfate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Hydroxychloroquine Sulfate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 400 |
| Active Ingredient Units | mg/1 |
| Substance Name | HYDROXYCHLOROQUINE SULFATE |
| Labeler Name | Accord Healthcare, Inc., |
| Pharmaceutical Class | Antimalarial [EPC], Antirheumatic Agent [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA213342 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 16729-0563-01 (16729056301)
| NDC Package Code | 16729-563-01 |
|---|---|
| Billing NDC | 16729056301 |
| Package | 100 TABLET in 1 BOTTLE (16729-563-01) |
| Marketing Start Date | 2021-09-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |