Prescription drug · ANDA
Hydroxychloroquine Sulfate NDC 50268-412
Hydroxychloroquine sulfate 200 mg/1 · Tablet, Film coated · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-412-15 | 50268041215 | 50 BLISTER PACK in 1 BOX (50268-412-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-412-11)Marketed from May 15, 2020 |
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
- AvPAK
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210441
- Marketing start
- Listing expires
- Identifiers
- Product ID 50268-412_47e560c6-bd1f-1264-e063-6394a90a0048SPL ID 47e560c6-bd1f-1264-e063-6394a90a0048SPL set ID a5b3455a-e842-7d4b-e053-2995a90adee3RxCUI 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
N450268041215followed by a unit qualifier and the quantityPackage 50268-0412-15. 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)
INDICATIONS AND USAGE Malaria Hydroxychloroquine Sulfate Tablets are indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale , and P. vivax. Hydroxychloroquine Sulfate Tablets are indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. Limitations of Use in Malaria Hydroxychloroquine Sulfate Tablets are not recommended for the treatment of complicated malaria. Hydroxychloroquine Sulfate Tablets are not effective against chloroquine or hydroxychloroquine- resistant strains of Plasmodium species (see CLINICAL PHARMACOLOGY – Microbiology ). Hydroxychloroquine Sulfate Tablets are not recommended for the t…
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 | Major Pharmaceuticals | 0904-7046 |