Dapsone NDC 46708-551

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-551Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0551Add 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
46708-551-30	46708055130	1 TUBE in 1 CARTON (46708-551-30) / 30 g in 1 TUBEMarketed from Jul 1, 2026
46708-551-60	46708055160	1 TUBE in 1 CARTON (46708-551-60) / 60 g in 1 TUBEMarketed from Jul 1, 2026
46708-551-90	46708055190	1 TUBE in 1 CARTON (46708-551-90) / 90 g in 1 TUBEMarketed from Jul 1, 2026

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
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213414
Marketing start: Jul 1, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Sulfones (Chemical structure)
Identifiers: Product ID 46708-551_1a5c37bb-155e-4a03-afc6-4a4ef1f9dce1SPL ID 1a5c37bb-155e-4a03-afc6-4a4ef1f9dce1SPL set ID 0f1301f6-884d-4fc7-a5b2-421b2375b985RxCUI 607295UNII 8W5C518302UPC 0346708551605
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

N446708055130 followed by a unit qualifier and the quantity

Package 46708-0551-30. 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 Jul 9, 2026.

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 213414

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

FDA NDC Directory listings under ANDA 213414
Product	Strength	Form · route	Labeler	Product NDC
Dapsone	Dapsone 50 mg/g	GelTopical	Alembic Pharmaceuticals Inc.	62332-551