Plaquenil (hydroxychloroquine sulfate) NDC 59212-562

NDC codes

FDA NDC Directory

Product NDC (as listed)59212-562Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59212-0562Add 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
59212-562-10	59212056210	100 TABLET in 1 BOTTLE (59212-562-10)Marketed from Jun 28, 2013
59212-562-11	59212056211	100 TABLET in 1 BOTTLE (59212-562-11)Marketed from Aug 10, 2020
59212-562-60	59212056260	60 TABLET in 1 BOTTLE (59212-562-60)Marketed from Jan 5, 2019

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: Advanz Pharma (US) Corp.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 009768
Marketing start: Jun 28, 2013
Listing expires: Dec 31, 2027
Identifiers: Product ID 59212-562_1138fd4e-dfba-4c96-a5ec-60f8bc1ba746SPL ID 1138fd4e-dfba-4c96-a5ec-60f8bc1ba746SPL set ID 34496b43-05a2-45fb-a769-52b12e099341RxCUI 979092, 979094UNII 8Q2869CNVHUPC 0359212562104
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

N459212056210 followed by a unit qualifier and the quantity

Package 59212-0562-10. 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 9, 2026.

Indications (excerpt from the label)

PLAQUENIL is 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): PLAQUENIL is not recommended for the: • Treatment of complicated malaria. • Treatment of chloroquine or hydroxychloroquine-resista…

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	Proficient Rx LP	71205-448