Hydroxychloroquine Sulfate NDC 71335-1523

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-1523Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-1523Add 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
71335-1523-1	71335152301	100 TABLET, FILM COATED in 1 BOTTLE (71335-1523-1)Marketed from Mar 26, 2020
71335-1523-2	71335152302	30 TABLET, FILM COATED in 1 BOTTLE (71335-1523-2)Marketed from Mar 13, 2020
71335-1523-3	71335152303	60 TABLET, FILM COATED in 1 BOTTLE (71335-1523-3)Marketed from Aug 3, 2020
71335-1523-4	71335152304	180 TABLET, FILM COATED in 1 BOTTLE (71335-1523-4)Marketed from Sep 21, 2022
71335-1523-5	71335152305	90 TABLET, FILM COATED in 1 BOTTLE (71335-1523-5)Marketed from Feb 26, 2020
71335-1523-6	71335152306	120 TABLET, FILM COATED in 1 BOTTLE (71335-1523-6)Marketed from Sep 21, 2022
71335-1523-7	71335152307	10 TABLET, FILM COATED in 1 BOTTLE (71335-1523-7)Marketed from Sep 21, 2022
71335-1523-8	71335152308	14 TABLET, FILM COATED in 1 BOTTLE (71335-1523-8)Marketed from Sep 21, 2022
71335-1523-9	71335152309	20 TABLET, FILM COATED in 1 BOTTLE (71335-1523-9)Marketed from Sep 21, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210577
Marketing start: May 17, 2018
Listing expires: Dec 31, 2027
Identifiers: Product ID 71335-1523_798a79ff-009e-4199-94c4-4435d5768e75SPL ID 798a79ff-009e-4199-94c4-4435d5768e75SPL set ID da435181-0c5a-4188-8d59-51234116b005RxCUI 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

N471335152301 followed by a unit qualifier and the quantity

Package 71335-1523-01. 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 Jun 29, 2026.

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. Treatme…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210577

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

FDA NDC Directory listings under ANDA 210577
Product	Strength	Form · route	Labeler	Product NDC
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-4659
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	60219-1544
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	69238-1544
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-961