Hydroxychloroquine Sulfate NDC 16729-561

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-561Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0561Add 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
16729-561-01	16729056101	100 TABLET in 1 BOTTLE (16729-561-01)Marketed from Sep 28, 2021

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 — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Accord Healthcare, Inc.,
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213342
Marketing start: Sep 28, 2021
Listing expires: Dec 31, 2027
Identifiers: Product ID 16729-561_4e68b971-e226-d3ff-e063-6294a90ae772SPL ID 4e68b971-e226-d3ff-e063-6294a90ae772SPL set ID 84b00366-96ef-41e1-bac6-5d24acdb9e1dRxCUI 979092, 1119312, 2569281, 2569283UNII 8Q2869CNVHUPC 0316729561013
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

N416729056101 followed by a unit qualifier and the quantity

Package 16729-0561-01. 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 Apr 1, 2026.

Indications (excerpt from the label)

Hydroxychloroquine sulfate 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 ) : Hydroxychloroquine sulfate is not recommended for the: Treatment of complicated malaria. Treatment of chloroqu…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213342

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

FDA NDC Directory listings under ANDA 213342
Product	Strength	Form · route	Labeler	Product NDC
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	TabletOral	A-S Medication Solutions	50090-6280
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	TabletOral	Accord Healthcare, Inc.,	16729-485
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 400 mg/1	TabletOral	Accord Healthcare, Inc.,	16729-563
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 300 mg/1	TabletOral	Accord Healthcare, Inc.,	16729-562