Dapsone NDC 16714-975

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-975Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0975Add 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 NDC	11-digit (billing)	Package	Copy
16714-975-01	16714097501	1 BOTTLE, PUMP in 1 CARTON (16714-975-01) / 60 g in 1 BOTTLE, PUMPMarketed from Oct 6, 2023
16714-975-02	16714097502	1 BOTTLE, PUMP in 1 CARTON (16714-975-02) / 90 g in 1 BOTTLE, PUMPMarketed from Oct 6, 2023

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 — 75 mg/g
Dosage form: Gel
Route: Topical
Labeler: NORTHSTAR RX LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210191
Marketing start: Oct 6, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Sulfones (Chemical structure)
Identifiers: Product ID 16714-975_3980db5f-3ff2-2443-e063-6394a90ab484SPL ID 3980db5f-3ff2-2443-e063-6394a90ab484SPL set ID 51ebcb4d-4368-4748-a6f3-1ec2100fed63RxCUI 1741905UNII 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

N416714097501 followed by a unit qualifier and the quantity

Package 16714-0975-01. 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 Jul 9, 2025.

Indications (excerpt from the label)

Dapsone gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Dapsone gel, 7.5%, is a sulfone indicated for the topical treatment of acne vulgaris in patients 9 years of age and older ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210191

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

FDA NDC Directory listings under ANDA 210191
Product	Strength	Form · route	Labeler	Product NDC
Dapsone	Dapsone 75 mg/g	GelTopical	Sun Pharmaceutical Industries, Inc.	51672-1388