What is NDC 16729-562?

16729-562 is the product NDC for Hydroxychloroquine Sulfate, Hydroxychloroquine sulfate 300 mg/1 tablet, listed with the FDA by Accord Healthcare, Inc.,. It has 1 package NDC, shown above in 10- and 11-digit form.

Accord Healthcare, Inc.,, NDC labeler code 16729. 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 16729-562

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-562Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0562Add 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
16729-562-01	1672905620116729056201	100 TABLET in 1 BOTTLE (16729-562-01)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 — 300 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Accord Healthcare, Inc.,NDC labeler code 16729
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 16729-562_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

N416729056201 followed by a unit qualifier and the quantity

Package 16729-0562-01. 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)

About NDC 16729-562

What is NDC 16729-562?: 16729-562 is the product NDC for Hydroxychloroquine Sulfate, Hydroxychloroquine sulfate 300 mg/1 tablet, listed with the FDA by Accord Healthcare, Inc.,. It has 1 package NDC, 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?: Accord Healthcare, Inc.,, NDC labeler code 16729. 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 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	Accord Healthcare, Inc.,	16729-485
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 100 mg/1	TabletOral	Accord Healthcare, Inc.,	16729-561
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 400 mg/1	TabletOral	Accord Healthcare, Inc.,	16729-563
Hydroxychloroquine Sulfate	Hydroxychloroquine sulfate 200 mg/1	TabletOral	A-S Medication Solutions	50090-6280