What is NDC 70771-1538?

70771-1538 is the product NDC for Dapsone, Dapsone 75 mg/g gel, listed with the FDA by Zydus Lifesciences Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Zydus Lifesciences Limited, NDC labeler code 70771. 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 70771-1538 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1538Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1538Add 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
70771-1538-2	7077115380270771153802	1 BOTTLE, PUMP in 1 CARTON (70771-1538-2) / 30 g in 1 BOTTLE, PUMPMarketed from May 10, 2024
70771-1538-3	7077115380370771153803	1 BOTTLE, PUMP in 1 CARTON (70771-1538-3) / 60 g in 1 BOTTLE, PUMPMarketed from May 10, 2024
70771-1538-8	7077115380870771153808	1 BOTTLE, PUMP in 1 CARTON (70771-1538-8) / 90 g in 1 BOTTLE, PUMPMarketed from May 10, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Zydus Lifesciences LimitedNDC labeler code 70771
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214019
Marketing start: May 10, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Sulfones (Chemical structure)
Identifiers: Product ID 70771-1538_ae448df2-611f-4d56-911f-11d01983726fSPL ID ae448df2-611f-4d56-911f-11d01983726fSPL set ID 8b63b653-0507-4f95-9bfa-70fd071e15a6RxCUI 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

N470771153802 followed by a unit qualifier and the quantity

Package 70771-1538-02. 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 9, 2024.

Full label on DailyMed (opens in a new tab)

About NDC 70771-1538

What is NDC 70771-1538?: 70771-1538 is the product NDC for Dapsone, Dapsone 75 mg/g gel, listed with the FDA by Zydus Lifesciences Limited. It has 3 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?: Zydus Lifesciences Limited, NDC labeler code 70771. 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

Other NDCs under ANDA 214019

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

FDA NDC Directory listings under ANDA 214019
Product	Strength	Form · route	Labeler	Product NDC
Dapsone	Dapsone 75 mg/g	GelTopical	Viona Pharmaceuticals Inc	72578-094