NDC codes

FDA NDC Directory
Product NDC (as listed)83209-566Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83209-0566Add 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
83209-566-30832090566308320905663030 TABLET in 1 BLISTER PACK (83209-566-30)Marketed from Aug 30, 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)
Dapsone
Generic name (nonproprietary)
dapsone
Active ingredients
Dapsone — 100 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207165
Marketing start
Listing expires
Other FDA classes
Sulfones (Chemical structure)
Identifiers
Product ID 83209-566_20e8edf4-4458-c1da-e063-6394a90aa891SPL ID 20e8edf4-4458-c1da-e063-6394a90aa891SPL set ID 20e8ca55-513e-8935-e063-6394a90a11cdRxCUI 197557UNII 8W5C518302
Pharmacologic class
Sulfone

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

N483209056630 followed by a unit qualifier and the quantity

Package 83209-0566-30. 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)

INDICATIONS & USAGE Dermatitis herpetiformis: (D.H.) Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83209-566

What is NDC 83209-566?
83209-566 is the product NDC for Dapsone, Dapsone 100 mg/1 tablet, listed with the FDA by Boswell Pharmacy Services LLC d/b/a BPS Wholesale. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dapsone.
What is the active ingredient?
Dapsone.
Who is the labeler?
Boswell Pharmacy Services LLC d/b/a BPS Wholesale, NDC labeler code 83209. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dapsone?
45 other product NDCs are listed under this name. See all Dapsone 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 Dapsone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DapsoneDapsone 25 mg/1TabletOralMacleods Pharmaceuticals Limited33342-53433342-0534-0733342-0534-11
DapsoneDapsone 100 mg/1TabletOralMacleods Pharmaceuticals Limited33342-53533342-0535-0733342-0535-11
DapsoneDapsone 50 mg/gGelTopicalAlembic Pharmaceuticals Limited46708-55146708-0551-3046708-0551-6046708-0551-90
DapsoneDapsone 50 mg/gGelTopicalAlembic Pharmaceuticals Inc.62332-55162332-0551-3062332-0551-6062332-0551-90
DapsoneDapsone 25 mg/1TabletOralZydus Lifesciences Limited70771-197970771-1979-0170771-1979-03
DapsoneDapsone 100 mg/1TabletOralZydus Lifesciences Limited70771-198070771-1980-0170771-1980-03
DapsoneDapsone 25 mg/1TabletOralViona Pharmaceuticals Inc72578-17772578-0177-0172578-0177-06
DapsoneDapsone 100 mg/1TabletOralViona Pharmaceuticals Inc72578-17872578-0178-0172578-0178-06
DapsoneDapsone 25 mg/1TabletOralAvKARE73190-03773190-0037-01
DapsoneDapsone 25 mg/1TabletOralWestminster Pharmaceuticals, LLC69367-40969367-0409-0169367-0409-30

All 46 Dapsone NDCs

Other NDCs under ANDA 207165

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

FDA NDC Directory listings under ANDA 207165
ProductStrengthForm · routeLabelerProduct NDC
DapsoneDapsone 100 mg/1TabletOralRising Pharma Holdings, Inc.64980-566
DapsoneDapsone 25 mg/1TabletOralRising Pharma Holdings, Inc.64980-567
DapsoneDapsone 100 mg/1TabletOralCoupler LLC67046-1477

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