Home NDC 46708-663 Dapsone
Product NDC 46708-663
11-digit product format 467080663
Labeler code 46708
Product ID 46708-663_f201a2ad-d969-428f-bb66-13401c124c0a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dapsone
Dosage form GEL
Route TOPICAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA215718
Marketing category ANDA
Marketing start 2023-10-30
Substance DAPSONE
Active strength 75 mg/g
Pharmacologic classes Sulfone [EPC], Sulfones [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215718-001 DAPSONE DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215718-001 AB
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 2026-02-19 14:30 UTC 2026-02 A215718-001 DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215718-001 DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215718-001 DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215718-001 DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215718-001 DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215718-001 DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215718-001 DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215718-001 DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215718-001 DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215718-001 DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215718-001 DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215718-001 DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215718-001 DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215718-001 DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215718-001 DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215718-001 DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215718-001 DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215718-001 DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215718-001 DAPSONE 7.5% GEL / TOPICAL AB 2023-10-27 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Dapsone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DAPSONE 75 mg/g
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1741905 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# 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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 46708-663-30 46708066330 1 BOTTLE, PUMP in 1 CARTON (46708-663-30) / 30 g in 1 BOTTLE, PUMP 2023-10-30 No No Current 46708-663-60 46708066360 1 BOTTLE, PUMP in 1 CARTON (46708-663-60) / 60 g in 1 BOTTLE, PUMP 2023-10-30 No No Current 46708-663-90 46708066390 1 BOTTLE, PUMP in 1 CARTON (46708-663-90) / 90 g in 1 BOTTLE, PUMP 2023-10-30 No No Current