What is NDC 83980-001?

83980-001 is the product NDC for Hydroxychloroquine Sulfate, Hydroxychloroquine sulfate 200 mg/1 tablet, film coated, listed with the FDA by Ipca Laboratories Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Ipca Laboratories Limited, NDC labeler code 83980. 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 83980-001

NDC codes

FDA NDC Directory

Product NDC (as listed)83980-001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83980-0001Add 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
83980-001-01	8398000010183980000101	100 TABLET, FILM COATED in 1 BOTTLE (83980-001-01)Marketed from Jun 3, 2024
83980-001-05	8398000010583980000105	500 TABLET, FILM COATED in 1 BOTTLE (83980-001-05)Marketed from Jun 3, 2024
83980-001-10	8398000011083980000110	1000 TABLET, FILM COATED in 1 BOTTLE (83980-001-10)Marketed from Jun 3, 2024
83980-001-97	8398000019783980000197	10 TABLET, FILM COATED in 1 BOTTLE (83980-001-97)Marketed from Jun 3, 2024

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: Ipca Laboratories LimitedNDC labeler code 83980
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040766
Marketing start: Jun 3, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 83980-001_31f4188d-1c26-4aab-aa12-354329160a39SPL ID 31f4188d-1c26-4aab-aa12-354329160a39SPL set ID 9dfa0ff8-e8cf-47f9-847a-b86f23dc39dfRxCUI 979092UNII 8Q2869CNVHUPC 0383980001015
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

N483980000101 followed by a unit qualifier and the quantity

Package 83980-0001-01. 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 Nov 19, 2024.

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 chloroquin…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83980-001

What is NDC 83980-001?: 83980-001 is the product NDC for Hydroxychloroquine Sulfate, Hydroxychloroquine sulfate 200 mg/1 tablet, film coated, listed with the FDA by Ipca Laboratories 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?: Ipca Laboratories Limited, NDC labeler code 83980. 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 040766

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

FDA NDC Directory listings under ANDA 040766
Product	Strength	Form · route	Labeler	Product NDC
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1523
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-3079