FDA.reportPublic FDA data

DAPSONE

Product NDC
59651-666
11-digit product format
596510666
Labeler code
59651
Product ID
59651-666_83966a34-02d4-4794-bc2b-3e612b121973
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DAPSONE
Dosage form
GEL
Route
TOPICAL
Labeler
Aurobindo Pharma Limited
Application
ANDA218457
Marketing category
ANDA
Marketing start
2025-04-04
Substance
DAPSONE
Active strength
50 mg/g
Pharmacologic classes
Sulfone [EPC], Sulfones [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218457-001DAPSONEDAPSONE5%GEL / TOPICALAB2025-04-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218457-001AB

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
2026-02-19 14:30 UTC2026-02A218457-001DAPSONE5%GEL / TOPICALAB2025-04-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218457-001DAPSONE5%GEL / TOPICALAB2025-04-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A218457-001DAPSONE5%GEL / TOPICALAB2025-04-046a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218457-001DAPSONE5%GEL / TOPICALAB2025-04-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218457-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218457-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218457-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218457-001AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPSONE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8W5C518302Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
607295Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
acd33f0b-8563-467a-93db-a11902331528Available on FDA.report

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
59651-666-60DAPSONE60 g in 1 TUBEGEL602
59651-666-60DAPSONE1 in 1 CARTONGEL12
59651-666-90DAPSONE1 in 1 CARTONGEL12
59651-666-90DAPSONE90 g in 1 TUBEGEL902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-666-60GM - Gram59651-666cd1f1ca3-9750-4e5f-9a65-2f36492bde9b12026-02-05
59651-666-90GM - Gram59651-666deda3d29-b6e2-44a5-9540-0332c1823dc312026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-666DAPSONE GEL [AUROBINDO PHARMA LIMITED]1Current NDC, 4 package rows20250418_acd33f0b-8563-467a-93db-a11902331528.zip

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
DAPSONEDAPSONEAurobindo Pharma Limitedacd33f0b-8563-467a-93db-a119023315282025-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218457
application number: ANDA218457
ndc (product): 59651-666

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
607295dapsone 5 % Topical GelPSNacd33f0b-8563-467a-93db-a119023315282
607295dapsone 0.05 MG/MG Topical GelSCDacd33f0b-8563-467a-93db-a119023315282
607295dapsone 5 % Topical GelSYacd33f0b-8563-467a-93db-a119023315282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-666-60596510666601 TUBE in 1 CARTON (59651-666-60) / 60 g in 1 TUBE1 tube2025-04-04NoNoCurrent
59651-666-90596510666901 TUBE in 1 CARTON (59651-666-90) / 90 g in 1 TUBE1 tube2025-04-04NoNoCurrent