Dapsone

Product NDC
70771-1980
11-digit product format
707711980
Labeler code
70771
Product ID
70771-1980_a4ce6655-3e02-434d-87ad-5bcec90202c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapsone
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA220103
Marketing category
ANDA
Marketing start
2026-02-27
Substance
DAPSONE
Active strength
100 mg/1
Pharmacologic classes
Sulfone [EPC], Sulfones [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dapsone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPSONE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W5C518302
Rxcui197557, 197558

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ae3f83f-9ccb-db71-5718-0b1e959868dfProduct name520260113
5ae2790a-f798-4a69-8811-64a4723c389aProduct name520250325
b8929bfc-0002-d39a-046d-72ddf714efbeProduct name620190618

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1980-1Dapsone100 in 1 BOTTLETABLET1001
70771-1980-3Dapsone30 in 1 BOTTLETABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197557dapsone 100 MG Oral TabletPSN1d6bc112-ba2f-40ab-975d-9cfbc853cd111
197558dapsone 25 MG Oral TabletPSN1d6bc112-ba2f-40ab-975d-9cfbc853cd111
197557dapsone 100 MG Oral TabletSCD1d6bc112-ba2f-40ab-975d-9cfbc853cd111
197558dapsone 25 MG Oral TabletSCD1d6bc112-ba2f-40ab-975d-9cfbc853cd111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1980-170771198001100 TABLET in 1 BOTTLE (70771-1980-1) 100 tablet2026-02-27NoNoCurrent
70771-1980-37077119800330 TABLET in 1 BOTTLE (70771-1980-3) 30 tablet2026-02-27NoNoCurrent