Hydroxychloroquine Sulfate NDC 16571-112

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-112Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0112Add 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
16571-112-01	16571011201	100 TABLET, FILM COATED in 1 BOTTLE (16571-112-01)Marketed from May 29, 2023
16571-112-06	16571011206	60 TABLET, FILM COATED in 1 BOTTLE (16571-112-06)Marketed from May 29, 2023
16571-112-10	16571011210	1000 TABLET, FILM COATED in 1 BOTTLE (16571-112-10)Marketed from May 29, 2023
16571-112-50	16571011250	500 TABLET, FILM COATED in 1 BOTTLE (16571-112-50)Marketed from May 29, 2023

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, Film coated
Route: Oral
Labeler: Rising Pharma Holdings, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210959
Marketing start: May 29, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 16571-112_40679f36-52b2-4c4f-9a83-cc0c136077efSPL ID 40679f36-52b2-4c4f-9a83-cc0c136077efSPL set ID 6837f2aa-1349-4b45-a0ac-09ec914fd764RxCUI 979092UNII 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

N416571011201 followed by a unit qualifier and the quantity

Package 16571-0112-01. 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 May 6, 2024.

Indications (excerpt from the label)

Hydroxychloroquine sulfate tablets are 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): Hydroxychloroquine sulfate tablets are not recommended for the: • Treatment of complicated malaria. • Tr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210959

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

FDA NDC Directory listings under ANDA 210959
Product	Strength	Form · route	Labeler	Product NDC
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-971