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 NDC11-digit (billing)PackageCopy
71335-1523-17133515230171335152301100 TABLET, FILM COATED in 1 BOTTLE (71335-1523-1)Marketed from Mar 26, 2020
71335-1523-2713351523027133515230230 TABLET, FILM COATED in 1 BOTTLE (71335-1523-2)Marketed from Mar 13, 2020
71335-1523-3713351523037133515230360 TABLET, FILM COATED in 1 BOTTLE (71335-1523-3)Marketed from Aug 3, 2020
71335-1523-47133515230471335152304180 TABLET, FILM COATED in 1 BOTTLE (71335-1523-4)Marketed from Sep 21, 2022
71335-1523-5713351523057133515230590 TABLET, FILM COATED in 1 BOTTLE (71335-1523-5)Marketed from Feb 26, 2020
71335-1523-67133515230671335152306120 TABLET, FILM COATED in 1 BOTTLE (71335-1523-6)Marketed from Sep 21, 2022
71335-1523-7713351523077133515230710 TABLET, FILM COATED in 1 BOTTLE (71335-1523-7)Marketed from Sep 21, 2022
71335-1523-8713351523087133515230814 TABLET, FILM COATED in 1 BOTTLE (71335-1523-8)Marketed from Sep 21, 2022
71335-1523-9713351523097133515230920 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 PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210577
Marketing start
Listing expires
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 .

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)

About NDC 71335-1523

What is NDC 71335-1523?
71335-1523 is the product NDC for Hydroxychloroquine Sulfate, Hydroxychloroquine sulfate 200 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 9 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Hydroxychloroquine SulfateHydroxychloroquine sulfate 200 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC53401-04053401-0040-5353401-0040-6053401-0040-70+1 more
Hydroxychloroquine SulfateHydroxychloroquine sulfate 200 mg/1TabletOralBryant Ranch Prepack71335-281371335-2813-01
Hydroxychloroquine SulfateHydroxychloroquine sulfate 200 mg/1TabletOralBryant Ranch Prepack71335-281471335-2814-01
Hydroxychloroquine SulfateHydroxychloroquine sulfate 200 mg/1TabletOralBryant Ranch Prepack71335-311371335-3113-0171335-3113-0271335-3113-03+6 more
Hydroxychloroquine SulfateHydroxychloroquine sulfate 200 mg/1TabletOralBryant Ranch Prepack71335-314271335-3142-0171335-3142-0271335-3142-03+6 more
Hydroxychloroquine SulfateHydroxychloroquine sulfate 200 mg/1TabletOralBryant Ranch Prepack72162-246772162-2467-0172162-2467-05
Hydroxychloroquine SulfateHydroxychloroquine sulfate 200 mg/1TabletOralCreekwood Pharmaceuticals LLC82619-13182619-0131-0182619-0131-0282619-0131-03
Hydroxychloroquine SulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-88959651-0889-0159651-0889-05
Hydroxychloroquine SulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralCoupler LLC67046-152367046-1523-03
Hydroxychloroquine SulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-307971335-3079-0171335-3079-0271335-3079-03+6 more

All 52 Hydroxychloroquine Sulfate NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
Hydroxychloroquine SulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4659
Hydroxychloroquine SulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals NY LLC60219-1544
Hydroxychloroquine SulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals NY LLC69238-1544
Hydroxychloroquine SulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-961

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in