NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0897Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0897Add 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
71335-0897-17133508970171335089701100 TABLET, FILM COATED in 1 BOTTLE (71335-0897-1)Marketed from Jul 14, 2020
71335-0897-2713350897027133508970230 TABLET, FILM COATED in 1 BOTTLE (71335-0897-2)Marketed from Mar 13, 2020
71335-0897-3713350897037133508970360 TABLET, FILM COATED in 1 BOTTLE (71335-0897-3)Marketed from Jul 6, 2018
71335-0897-47133508970471335089704180 TABLET, FILM COATED in 1 BOTTLE (71335-0897-4)Marketed from Jul 10, 2018
71335-0897-5713350897057133508970590 TABLET, FILM COATED in 1 BOTTLE (71335-0897-5)Marketed from Feb 25, 2019
71335-0897-67133508970671335089706120 TABLET, FILM COATED in 1 BOTTLE (71335-0897-6)Marketed from Jul 9, 2024
71335-0897-7713350897077133508970710 TABLET, FILM COATED in 1 BOTTLE (71335-0897-7)Marketed from Jul 9, 2024
71335-0897-8713350897087133508970814 TABLET, FILM COATED in 1 BOTTLE (71335-0897-8)Marketed from Jul 9, 2024
71335-0897-9713350897097133508970920 TABLET, FILM COATED in 1 BOTTLE (71335-0897-9)Marketed from Jul 9, 2024

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 040657
Marketing start
Listing expires
Identifiers
Product ID 71335-0897_c325a7fe-e4d3-40df-a21d-e17a8e8a3b7bSPL ID c325a7fe-e4d3-40df-a21d-e17a8e8a3b7bSPL set ID f618a091-ade1-4c39-ab76-f6218b606e05RxCUI 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

N471335089701 followed by a unit qualifier and the quantity

Package 71335-0897-01. 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 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 Tablets is not recommended for the: Treatment of complicated malaria. Treatment…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-0897

What is NDC 71335-0897?
71335-0897 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 040657

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

FDA NDC Directory listings under ANDA 040657
ProductStrengthForm · routeLabelerProduct NDC
Hydroxychloroquine sulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8459
Hydroxychloroquine sulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralNorthstar Rx LLC.16714-110
Hydroxychloroquine sulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5573
Hydroxychloroquine sulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6629
Hydroxychloroquine sulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7306
Hydroxychloroquine sulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7307
Hydroxychloroquine sulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-2074
Hydroxychloroquine sulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-633
Hydroxychloroquine sulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2332
Hydroxychloroquine sulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3955
Hydroxychloroquine SulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-269
Hydroxychloroquine sulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-096
Hydroxychloroquine sulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc.68788-7747
Hydroxychloroquine sulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-506
Hydroxychloroquine sulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-850
Hydroxychloroquine sulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-045

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