NDC codes

FDA NDC Directory
Product NDC (as listed)68382-096Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68382-0096Add 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
68382-096-016838200960168382009601100 TABLET, FILM COATED in 1 BOTTLE (68382-096-01)Marketed from Jan 3, 2008
68382-096-056838200960568382009605500 TABLET, FILM COATED in 1 BOTTLE (68382-096-05)Marketed from Jan 3, 2008
68382-096-776838200967768382009677100 BLISTER PACK in 1 CARTON (68382-096-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-096-30)Marketed from Jan 3, 2008

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
Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040657
Marketing start
Listing expires
Identifiers
Product ID 68382-096_8b9ea8e4-c27b-4b81-b8d0-2d5eddcec21aSPL ID 8b9ea8e4-c27b-4b81-b8d0-2d5eddcec21aSPL set ID 805a1acd-2e0d-48f1-af6b-0e5d8e06c228RxCUI 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

N468382009601 followed by a unit qualifier and the quantity

Package 68382-0096-01. 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 68382-096

What is NDC 68382-096?
68382-096 is the product NDC for Hydroxychloroquine sulfate, Hydroxychloroquine sulfate 200 mg/1 tablet, film coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 3 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?
Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 coatedOralPreferred Pharmaceuticals, Inc.68788-7747
Hydroxychloroquine sulfateHydroxychloroquine sulfate 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0897
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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