Prescription drug · ANDA
Hydroxychloroquine Sulfate NDC 71335-1771
Hydroxychloroquine sulfate 200 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1771-1 | 71335177101 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1771-1)Marketed from Sep 2, 2021 | |
| 71335-1771-2 | 71335177102 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1771-2)Marketed from Aug 19, 2021 | |
| 71335-1771-3 | 71335177103 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1771-3)Marketed from Dec 29, 2021 | |
| 71335-1771-4 | 71335177104 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1771-4)Marketed from Jan 21, 2021 | |
| 71335-1771-5 | 71335177105 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1771-5)Marketed from Dec 29, 2021 | |
| 71335-1771-6 | 71335177106 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1771-6)Marketed from Dec 29, 2021 | |
| 71335-1771-7 | 71335177107 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-1771-7)Marketed from Aug 16, 2021 | |
| 71335-1771-8 | 71335177108 | 14 TABLET, FILM COATED in 1 BOTTLE (71335-1771-8)Marketed from Dec 29, 2021 | |
| 71335-1771-9 | 71335177109 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1771-9)Marketed from Aug 18, 2021 |
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, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040081
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-1771_34ede119-f969-48e4-a54a-6050323002a7SPL ID 34ede119-f969-48e4-a54a-6050323002a7SPL set ID cf4b1912-9806-4ef3-bf17-152a96d75bbcRxCUI 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
N471335177101followed by a unit qualifier and the quantityPackage 71335-1771-01. 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 tablets are 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 are not recommended for the: Treatment of complicated malaria. Trea…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040081
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 | Teva Pharmaceuticals USA, Inc. | 0093-2401 |