Prescription drug · ANDA
Hydroxychloroquine Sulfate NDC 63629-4465
Hydroxychloroquine sulfate 300 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-4465-1 | 63629446501 | 30 TABLET in 1 BOTTLE (63629-4465-1)Marketed from Aug 16, 2024 | |
| 63629-4465-2 | 63629446502 | 14 TABLET in 1 BOTTLE (63629-4465-2)Marketed from Aug 16, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210441
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-4465_55eb56c0-c585-4373-a3a4-9276aaeae6d6SPL ID 55eb56c0-c585-4373-a3a4-9276aaeae6d6SPL set ID 2c109188-d28b-4c65-8b52-819bd8547f2eRxCUI 2569283UNII 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
N463629446501followed by a unit qualifier and the quantityPackage 63629-4465-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 210441
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 | Cardinal Health 107, LLC | 55154-3567 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 400 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-131 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-721 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 300 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-132 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 100 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-133 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-701 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7046 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-412 |