What is NDC 0378-4830?

0378-4830 is the product NDC for Dapsone, Dapsone 75 mg/g gel, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dapsone NDC 0378-4830 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-4830Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-4830Add 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
0378-4830-60	0037848306000378483060	1 BOTTLE, PUMP in 1 CARTON (0378-4830-60) / 60 g in 1 BOTTLE, PUMPMarketed from May 20, 2022
0378-4830-90	0037848309000378483090	1 BOTTLE, PUMP in 1 CARTON (0378-4830-90) / 90 g in 1 BOTTLE, PUMPMarketed from May 20, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213847
Marketing start: May 20, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Sulfones (Chemical structure)
Identifiers: Product ID 0378-4830_9feeeb14-77f7-47c7-816f-515ea0a60463SPL ID 9feeeb14-77f7-47c7-816f-515ea0a60463SPL set ID e04da0a1-d02a-487d-a931-a31034738fddRxCUI 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

N400378483060 followed by a unit qualifier and the quantity

Package 00378-4830-60. 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 May 31, 2024.

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)

About NDC 0378-4830

What is NDC 0378-4830?: 0378-4830 is the product NDC for Dapsone, Dapsone 75 mg/g gel, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dapsone	Dapsone 25 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-534	33342-0534-0733342-0534-11
Dapsone	Dapsone 100 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-535	33342-0535-0733342-0535-11
Dapsone	Dapsone 50 mg/g	GelTopical	Alembic Pharmaceuticals Limited	46708-551	46708-0551-3046708-0551-6046708-0551-90
Dapsone	Dapsone 50 mg/g	GelTopical	Alembic Pharmaceuticals Inc.	62332-551	62332-0551-3062332-0551-6062332-0551-90
Dapsone	Dapsone 25 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1979	70771-1979-0170771-1979-03
Dapsone	Dapsone 100 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1980	70771-1980-0170771-1980-03
Dapsone	Dapsone 25 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-177	72578-0177-0172578-0177-06
Dapsone	Dapsone 100 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-178	72578-0178-0172578-0178-06
Dapsone	Dapsone 25 mg/1	TabletOral	AvKARE	73190-037	73190-0037-01
Dapsone	Dapsone 25 mg/1	TabletOral	Westminster Pharmaceuticals, LLC	69367-409	69367-0409-0169367-0409-30

All 46 Dapsone NDCs