Prescription drug · ANDA
Hydroxychloroquine sulfate NDC 82009-045
Hydroxychloroquine sulfate 200 mg/1 · Tablet, Film coated · Oral · Quallent Pharmaceuticals Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82009-045-05 | 82009004505 | 500 TABLET, FILM COATED in 1 BOTTLE (82009-045-05)Marketed from Sep 30, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Hydroxychloroquine sulfate
- Generic name (nonproprietary)
- hydroxychloroquine sulfate
- Active ingredients
- Hydroxychloroquine sulfate — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040657
- Marketing start
- Listing expires
- Identifiers
- Product ID 82009-045_ddd9bc99-2f96-4baf-82a4-6fb27a3bdc07SPL ID ddd9bc99-2f96-4baf-82a4-6fb27a3bdc07SPL set ID 81e68f23-b1bf-4561-8f02-a472631acfafRxCUI 979092UNII 8Q2869CNVH
- Pharmacologic class
- Antimalarial; Antirheumatic Agent
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N482009004505followed by a unit qualifier and the quantityPackage 82009-0045-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Hydroxychloroquine sulfate tablets is an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. ( 1.1 ) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. ( 1.1 ) Treatment of rheumatoid arthritis in adults. ( 1.2 ) Treatment of systemic lupus erythematosus in adults. ( 1.3 ) Treatment of chronic discoid lupus erythematosus in adults. ( 1.4 ) Limitations of Use (1.1): Hydroxychloroquine sulfate Tablets is not recommended for the: Treatment of complicated malaria. Treatment…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040657
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Hydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-506 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-269 |
| Hydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | Northstar Rx LLC. | 16714-110 |
| Hydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3955 |
| Hydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5573 |
| Hydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2332 |
| Hydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-096 |
| Hydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8459 |
| Hydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-7747 |
| Hydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2074 |
| Hydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-850 |
| Hydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6629 |
| Hydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7307 |
| Hydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7306 |
| Hydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-633 |
| Hydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0897 |