Prescription drug · ANDA
Hydroxychloroquine Sulfate NDC 50090-6280
Hydroxychloroquine sulfate 200 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6280-1 | 50090628001 | 60 TABLET in 1 BOTTLE (50090-6280-1)Marketed from Dec 15, 2022 | |
| 50090-6280-2 | 50090628002 | 90 TABLET in 1 BOTTLE (50090-6280-2)Marketed from Dec 15, 2022 |
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 — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213342
- Marketing start
- Listing expires
- Identifiers
- Product ID 50090-6280_e3ddf397-4b8f-40cf-adbc-d1f056fc27a6SPL ID e3ddf397-4b8f-40cf-adbc-d1f056fc27a6SPL set ID b4dca05a-745f-4c15-b731-1e99176cf44cRxCUI 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
N450090628001followed by a unit qualifier and the quantityPackage 50090-6280-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Hydroxychloroquine sulfate 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 is not recommended for the: Treatment of complicated malaria. Treatment of chloroqu…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213342
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 | TabletOral | Accord Healthcare, Inc., | 16729-485 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 400 mg/1 | TabletOral | Accord Healthcare, Inc., | 16729-563 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 100 mg/1 | TabletOral | Accord Healthcare, Inc., | 16729-561 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 300 mg/1 | TabletOral | Accord Healthcare, Inc., | 16729-562 |