Hydroxychloroquine Sulfate NDC 42385-971

NDC codes

FDA NDC Directory

Product NDC (as listed)42385-971Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42385-0971Add 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
42385-971-01	42385097101	100 TABLET, FILM COATED in 1 BOTTLE (42385-971-01)Marketed from Mar 6, 2023
42385-971-05	42385097105	500 TABLET, FILM COATED in 1 BOTTLE (42385-971-05)Marketed from Mar 6, 2023
42385-971-11	42385097111	1000 TABLET, FILM COATED in 1 BOTTLE (42385-971-11)Marketed from Mar 6, 2023
42385-971-60	42385097160	60 TABLET, FILM COATED in 1 BOTTLE (42385-971-60)Marketed from Mar 6, 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: Laurus Labs Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210959
Marketing start: Mar 6, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 42385-971_5db4ef8e-532f-4bbe-94ec-489704e93be7SPL ID 5db4ef8e-532f-4bbe-94ec-489704e93be7SPL set ID 04d8fdbf-8829-4469-a341-8af2a2d91cccRxCUI 979092UNII 8Q2869CNVHUPC 0342385971606
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

N442385097101 followed by a unit qualifier and the quantity

Package 42385-0971-01. 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 Jan 5, 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 m…

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	Rising Pharma Holdings, Inc.	16571-112