Prescription drug · ANDA
Hydroxychloroquine Sulfate NDC 53401-040
Hydroxychloroquine sulfate 200 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53401-040-53 | 53401004053 | 60 TABLET in 1 BOTTLE (53401-040-53)Marketed from Sep 28, 2026 | |
| 53401-040-60 | 53401004060 | 90 TABLET in 1 BOTTLE (53401-040-60)Marketed from Sep 28, 2026 | |
| 53401-040-70 | 53401004070 | 120 TABLET in 1 BOTTLE (53401-040-70)Marketed from Sep 28, 2026 | |
| 53401-040-80 | 53401004080 | 180 TABLET in 1 BOTTLE (53401-040-80)Marketed from Sep 28, 2026 |
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
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 53401
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040150
- Marketing start
- Listing expires
- Identifiers
- Product ID 53401-040_5ca218be-a1de-5471-e063-6394a90a97daSPL ID 5ca218be-a1de-5471-e063-6394a90a97da
- 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
N453401004053followed by a unit qualifier and the quantityPackage 53401-0040-53. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 53401-040
- What is NDC 53401-040?
- 53401-040 is the product NDC for Hydroxychloroquine Sulfate, Hydroxychloroquine sulfate 200 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydroxychloroquine Sulfate.
- What is the active ingredient?
- Hydroxychloroquine sulfate.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 53401. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydroxychloroquine Sulfate?
- 51 other product NDCs are listed under this name. See all Hydroxychloroquine Sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydroxychloroquine Sulfate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2813 | 71335-2813-01 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2814 | 71335-2814-01 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3113 | 71335-3113-0171335-3113-0271335-3113-03+6 more |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3142 | 71335-3142-0171335-3142-0271335-3142-03+6 more |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2467 | 72162-2467-0172162-2467-05 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Creekwood Pharmaceuticals LLC | 82619-131 | 82619-0131-0182619-0131-0282619-0131-03 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-889 | 59651-0889-0159651-0889-05 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1523 | 67046-1523-03 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3079 | 71335-3079-0171335-3079-0271335-3079-03+6 more |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | Ipca Laboratories Limited | 83980-001 | 83980-0001-0183980-0001-0583980-0001-10+1 more |
Other NDCs under ANDA 040150
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 | Bryant Ranch Prepack | 71335-2813 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2814 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3113 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3142 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2467 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Creekwood Pharmaceuticals LLC | 82619-131 |