Plaquenil (hydroxychloroquine sulfate) NDC 71205-448

NDC codes

FDA NDC Directory

Product NDC (as listed)71205-448Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71205-0448Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
71205-448-12	71205044812	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 LP
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 009768
Marketing start: Jun 28, 2013
Listing expires: Dec 31, 2026
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

N471205044812 followed by a unit qualifier and the quantity

Package 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 Apr 1, 2020.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 009768

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 009768
Product	Strength	Form · route	Labeler	Product NDC
Plaquenilhydroxychloroquine sulfate	Hydroxychloroquine sulfate 200 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-473
Plaquenilhydroxychloroquine sulfate	Hydroxychloroquine sulfate 200 mg/1	TabletOral	Advanz Pharma (US) Corp.	59212-562