NDC codes

FDA NDC Directory
Product NDC (as listed)85185-104Labeler and product segments. Claims need a package NDC.
Product NDC at billing width85185-0104Add 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
85185-104-018518501040130 TABLET in 1 BOTTLE (85185-104-01)Marketed from May 9, 2016
85185-104-0285185010402100 TABLET in 1 BOTTLE (85185-104-02)Marketed from May 9, 2016

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 25mg
Generic name (nonproprietary)
dapsone 25mg
Active ingredients
Dapsone — 25 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203887
Marketing start
Listing expires
Other FDA classes
Sulfones (Chemical structure)
Identifiers
Product ID 85185-104_50209cd1-afc6-53f4-e063-6394a90af9cfSPL ID 50209cd1-afc6-53f4-e063-6394a90af9cfSPL set ID 50204029-4c29-5b8d-e063-6394a90af383RxCUI 197557, 197558UNII 8W5C518302UPC 0385185105024
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

N485185010401 followed by a unit qualifier and the quantity

Package 85185-0104-01. 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)

INDICATIONS AND 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)

Other NDCs under ANDA 203887

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

FDA NDC Directory listings under ANDA 203887
ProductStrengthForm · routeLabelerProduct NDC
Dapsone 100mgDapsone 100 mg/1TabletOralSolis Pharmaceuticals Inc.85185-105
DapsoneDapsone 25 mg/1TabletOralGolden State Medical Supply, Inc.60429-495

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