What is NDC 42385-971?

42385-971 is the product NDC for Hydroxychloroquine Sulfate, Hydroxychloroquine sulfate 200 mg/1 tablet, film coated, listed with the FDA by Laurus Labs Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Laurus Labs Limited, NDC labeler code 42385. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Hydroxychloroquine Sulfate?

51 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

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	4238509710142385097101	100 TABLET, FILM COATED in 1 BOTTLE (42385-971-01)Marketed from Mar 6, 2023
42385-971-05	4238509710542385097105	500 TABLET, FILM COATED in 1 BOTTLE (42385-971-05)Marketed from Mar 6, 2023
42385-971-11	4238509711142385097111	1000 TABLET, FILM COATED in 1 BOTTLE (42385-971-11)Marketed from Mar 6, 2023
42385-971-60	4238509716042385097160	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 LimitedNDC labeler code 42385
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)

About NDC 42385-971

What is NDC 42385-971?: 42385-971 is the product NDC for Hydroxychloroquine Sulfate, Hydroxychloroquine sulfate 200 mg/1 tablet, film coated, listed with the FDA by Laurus Labs Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Hydroxychloroquine Sulfate.
What is the active ingredient?: Hydroxychloroquine sulfate.
Who is the labeler?: Laurus Labs Limited, NDC labeler code 42385. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hydroxychloroquine Sulfate?: 51 other product NDCs are listed under this name. See all Hydroxychloroquine Sulfate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Hydroxychloroquine Sulfate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	53401-040	53401-0040-5353401-0040-6053401-0040-70+1 more
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	TabletOral	Bryant Ranch Prepack	71335-2813	71335-2813-01
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	TabletOral	Bryant Ranch Prepack	71335-2814	71335-2814-01
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	TabletOral	Bryant Ranch Prepack	71335-3113	71335-3113-0171335-3113-0271335-3113-03+6 more
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	TabletOral	Bryant Ranch Prepack	71335-3142	71335-3142-0171335-3142-0271335-3142-03+6 more
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	TabletOral	Bryant Ranch Prepack	72162-2467	72162-2467-0172162-2467-05
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	TabletOral	Creekwood Pharmaceuticals LLC	82619-131	82619-0131-0182619-0131-0282619-0131-03
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-889	59651-0889-0159651-0889-05
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1523	67046-1523-03
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-3079	71335-3079-0171335-3079-0271335-3079-03+6 more

All 52 Hydroxychloroquine Sulfate NDCs

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