Plaquenil (hydroxychloroquine sulfate) NDC 71610-473

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-473Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0473Add 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
71610-473-04	71610047304	4000 TABLET in 1 BOTTLE (71610-473-04)Marketed from Apr 3, 2024
71610-473-30	71610047330	30 TABLET in 1 BOTTLE (71610-473-30)Marketed from Oct 14, 2020
71610-473-53	71610047353	60 TABLET in 1 BOTTLE (71610-473-53)Marketed from Oct 14, 2020
71610-473-74	71610047374	500 TABLET in 1 BOTTLE (71610-473-74)Marketed from Mar 24, 2023
71610-473-80	71610047380	180 TABLET in 1 BOTTLE (71610-473-80)Marketed from Dec 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: Aphena Pharma Solutions - Tennessee, LLC
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 71610-473_1546d08e-f1f4-7d0b-e063-6294a90a633fSPL ID 1546d08e-f1f4-7d0b-e063-6294a90a633fSPL set ID eb26c050-fc41-4183-9f8c-86351335fa64RxCUI 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

N471610047304 followed by a unit qualifier and the quantity

Package 71610-0473-04. 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 4, 2024.

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-resistan…

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	Proficient Rx LP	71205-448
Plaquenilhydroxychloroquine sulfate	Hydroxychloroquine sulfate 200 mg/1	TabletOral	Advanz Pharma (US) Corp.	59212-562