Prescription drug · ANDA
Hydroxychloroquine Sulfate NDC 0904-7046
Hydroxychloroquine sulfate 200 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7046-06 | 00904704606 | 50 BLISTER PACK in 1 CARTON (0904-7046-06) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 1, 2018 | |
| 0904-7046-61 | 00904704661 | 100 BLISTER PACK in 1 CARTON (0904-7046-61) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 1, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210441
- Marketing start
- Listing expires
- Identifiers
- Product ID 0904-7046_32eabaf6-e837-4b40-bee2-dbeea2238e2cSPL ID 32eabaf6-e837-4b40-bee2-dbeea2238e2cSPL set ID ebe00e35-ed3d-40f4-9a93-a37b0da01ddbRxCUI 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
N400904704606followed by a unit qualifier and the quantityPackage 00904-7046-06. 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. • Tre…
Excerpt only. Read the full label for complete information.
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 300 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-4465 |
| 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 | AvPAK | 50268-412 |