NDC codes

FDA NDC Directory
Product NDC (as listed)16714-956Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0956Add 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
16714-956-01167140956011 TUBE in 1 CARTON (16714-956-01) / 60 g in 1 TUBEMarketed from Apr 25, 2019
16714-956-02167140956021 TUBE in 1 CARTON (16714-956-02) / 90 g in 1 TUBEMarketed from Apr 25, 2019

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 — 50 mg/g
Dosage form
Gel
Route
Topical
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209506
Marketing start
Listing expires
Other FDA classes
Sulfones (Chemical structure)
Identifiers
Product ID 16714-956_3980a223-560e-186f-e063-6394a90a0d68SPL ID 3980a223-560e-186f-e063-6394a90a0d68SPL set ID 91d027f1-cbc6-4066-870b-01b1ddb1f48fRxCUI 607295UNII 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N416714095601 followed by a unit qualifier and the quantity

Package 16714-0956-01. 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)

Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris. Dapsone gel is indicated for the topical treatment of acne vulgaris ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209506

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

FDA NDC Directory listings under ANDA 209506
ProductStrengthForm · routeLabelerProduct NDC
DapsoneDapsone 50 mg/gGelTopicalSun Pharmaceutical Industries, Inc.51672-1387

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