Prescription drug · ANDA
Hydroxychloroquine Sulfate NDC 83980-001
Hydroxychloroquine sulfate 200 mg/1 · Tablet, Film coated · Oral · Ipca Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83980-001-01 | 83980000101 | 100 TABLET, FILM COATED in 1 BOTTLE (83980-001-01)Marketed from Jun 3, 2024 | |
| 83980-001-05 | 83980000105 | 500 TABLET, FILM COATED in 1 BOTTLE (83980-001-05)Marketed from Jun 3, 2024 | |
| 83980-001-10 | 83980000110 | 1000 TABLET, FILM COATED in 1 BOTTLE (83980-001-10)Marketed from Jun 3, 2024 | |
| 83980-001-97 | 83980000197 | 10 TABLET, FILM COATED in 1 BOTTLE (83980-001-97)Marketed from Jun 3, 2024 |
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
- Labeler
- Ipca Laboratories Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040766
- Marketing start
- Listing expires
- Identifiers
- Product ID 83980-001_31f4188d-1c26-4aab-aa12-354329160a39SPL ID 31f4188d-1c26-4aab-aa12-354329160a39SPL set ID 9dfa0ff8-e8cf-47f9-847a-b86f23dc39dfRxCUI 979092UNII 8Q2869CNVHUPC 0383980001015
- 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
N483980000101followed by a unit qualifier and the quantityPackage 83980-0001-01. 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 chloroquin…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040766
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 | Coupler LLC | 67046-1523 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3079 |