Home NDC 33342-534-11 Dapsone
Product NDC 33342-534
Requested package NDC 33342-534-11
11-digit product format 333420534
Labeler code 33342
Product ID 33342-534_839d7440-ba0e-4c56-b648-d374b155cf03
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dapsone
Dosage form TABLET
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA218335
Marketing category ANDA
Marketing start 2026-07-08
Substance DAPSONE
Active strength 25 mg/1
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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218335-001 DAPSONE DAPSONE 25MG TABLET / ORAL AB 2026-07-08 A218335-002 DAPSONE DAPSONE 100MG TABLET / ORAL AB 2026-07-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A218335-001 DAPSONE 25MG TABLET / ORAL AB 2026-07-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218335-002 DAPSONE 100MG TABLET / ORAL AB 2026-07-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218335-001 DAPSONE 25MG TABLET / ORAL AB 2026-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218335-002 DAPSONE 100MG TABLET / ORAL AB 2026-07-08 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218335-001 DAPSONE 25MG TABLET / ORAL AB 2026-07-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218335-002 DAPSONE 100MG TABLET / ORAL AB 2026-07-08 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Dapsone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DAPSONE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8W5C518302 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197557 Internal RxNorm lookup 197558 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 33342-534-11 33342053411 100 TABLET in 1 BOTTLE (33342-534-11) 100 tablet 2026-07-08 No No Current