Prescription drug · NDA
Plaquenil (Hydroxychloroquine sulfate) NDC 71205-448
Hydroxychloroquine sulfate 200 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-448-12 | 7120504481271205044812 | 12 TABLET in 1 BOTTLE (71205-448-12)Marketed from Apr 8, 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)
- Plaquenil
- Generic name (nonproprietary)
- hydroxychloroquine sulfate
- Active ingredients
- Hydroxychloroquine sulfate — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 009768
- Marketing start
- Listing expires
- Identifiers
- Product ID 71205-448_8aec894d-5711-4079-b167-240713bf04f2SPL ID 8aec894d-5711-4079-b167-240713bf04f2SPL set ID 8aec894d-5711-4079-b167-240713bf04f2RxCUI 979092, 979094UNII 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
N471205044812followed by a unit qualifier and the quantityPackage 71205-0448-12. 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 PLAQUENIL is indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax . PLAQUENIL is indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. Limitations of Use in Malaria • PLAQUENIL is not recommended for the treatment of complicated malaria. • PLAQUENIL is not effective against chloroquine or hydroxychloroquine-resistant strains of Plasmodium species (see CLINICAL PHARMACOLOGY – Microbiology ). PLAQUENIL is not recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not bee…
Excerpt only. Read the full label for complete information.
About NDC 71205-448
- What is NDC 71205-448?
- 71205-448 is the product NDC for Plaquenil (hydroxychloroquine sulfate), Hydroxychloroquine sulfate 200 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Plaquenil (Hydroxychloroquine Sulfate).
- What is the active ingredient?
- Hydroxychloroquine sulfate.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 71205. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Plaquenil?
- 2 other product NDCs are listed under this name. See all Plaquenil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Plaquenil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Plaquenilhydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Advanz Pharma (US) Corp. | 59212-562 | 59212-0562-1059212-0562-1159212-0562-60 |
| Plaquenilhydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-473 | 71610-0473-0471610-0473-3071610-0473-53+2 more |
Other NDCs under NDA 009768
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 |
|---|---|---|---|---|
| Plaquenilhydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Advanz Pharma (US) Corp. | 59212-562 |
| Plaquenilhydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-473 |