FDA.reportPublic FDA data

Dapsone Tablets, USP

Manufacturer
Zydus Lifesciences Limited | Zydus Pharmaceuticals Limited
Effective date
2026-02-27
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:07:34

Label at a glance#

ProductDapsone
Active ingredientDAPSONE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1979-3 in bottle of 30 tablets

Dapsone Tablets USP, 25 mg

Rx only

30 tablets

25 mg label
25 mg label

NDC 70771-1980-3 in bottle of 30 tablets

Dapsone Tablets USP, 100 mg

Rx only

30 tablets

100 mg label
100 mg label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
197557dapsone 100 MG Oral TabletPSN1
197558dapsone 25 MG Oral TabletPSN1
197557dapsone 100 MG Oral TabletSCD1
197558dapsone 25 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DAPSONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
70771-1979-1Dapsone100 in 1 BOTTLETABLET1001
70771-1979-3Dapsone30 in 1 BOTTLETABLET301
70771-1980-1Dapsone100 in 1 BOTTLETABLET1001
70771-1980-3Dapsone30 in 1 BOTTLETABLET301

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-197970771-1979-1, 70771-1979-3
70771-198070771-1980-1, 70771-1980-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DAPSONE8W5C518302ACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
DAPSONE8W5C518302ACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220103-001DAPSONEDAPSONE25MGTABLET / ORALAB2026-02-26
A220103-002DAPSONEDAPSONE100MGTABLET / ORALAB2026-02-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A220103-001AB
A220103-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A220103-001DAPSONE25MGTABLET / ORALAB2026-02-2684e616aacf4f…
2026-09-14 22:38:342026-08A220103-002DAPSONE100MGTABLET / ORALAB2026-02-2684e616aacf4f…
2026-08-18 06:07:402026-07A220103-001DAPSONE25MGTABLET / ORALAB2026-02-26caaa826d4ba7…
2026-08-18 06:07:402026-07A220103-002DAPSONE100MGTABLET / ORALAB2026-02-26caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220103-001DAPSONE25MGTABLET / ORALAB2026-02-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220103-002DAPSONE100MGTABLET / ORALAB2026-02-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A220103-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A220103-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A220103-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A220103-002AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220103-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220103-002AB1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DapsoneDAPSONEZydus Lifesciences Limited1d6bc112-ba2f-40ab-975d-9cfbc853cd112026-02-27Exact identifier
ndc (package): 70771-1979-1
ndc (package): 70771-1979-3
ndc (package): 70771-1980-3
ndc (package): 70771-1980-1
ndc (product): 70771-1979
ndc (product): 70771-1980
ndc11 (package): 70771198001
ndc11 (package): 70771197903
ndc11 (package): 70771198003
ndc11 (package): 70771197901
spl id: a4ce6655-3e02-434d-87ad-5bcec90202c1
spl set id: 1d6bc112-ba2f-40ab-975d-9cfbc853cd11

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.