Home NDC 70771-1538 Dapsone
Product NDC 70771-1538
11-digit product format 707711538
Labeler code 70771
Product ID 70771-1538_ae448df2-611f-4d56-911f-11d01983726f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dapsone
Dosage form GEL
Route TOPICAL
Labeler Zydus Lifesciences Limited
Application ANDA214019
Marketing category ANDA
Marketing start 2024-05-10
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 A214019-001 DAPSONE DAPSONE 7.5% GEL / TOPICAL AB 2024-05-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214019-001 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 A214019-001 DAPSONE 7.5% GEL / TOPICAL AB 2024-05-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214019-001 DAPSONE 7.5% GEL / TOPICAL AB 2024-05-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214019-001 DAPSONE 7.5% GEL / TOPICAL AB 2024-05-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214019-001 DAPSONE 7.5% GEL / TOPICAL AB 2024-05-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214019-001 DAPSONE 7.5% GEL / TOPICAL AB 2024-05-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214019-001 DAPSONE 7.5% GEL / TOPICAL AB 2024-05-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214019-001 DAPSONE 7.5% GEL / TOPICAL AB 2024-05-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214019-001 DAPSONE 7.5% GEL / TOPICAL AB 2024-05-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214019-001 DAPSONE 7.5% GEL / TOPICAL AB 2024-05-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214019-001 DAPSONE 7.5% GEL / TOPICAL AB 2024-05-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214019-001 DAPSONE 7.5% GEL / TOPICAL AB 2024-05-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214019-001 DAPSONE 7.5% GEL / TOPICAL AB 2024-05-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214019-001 DAPSONE 7.5% GEL / TOPICAL AB 2024-05-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214019-001 DAPSONE 7.5% GEL / TOPICAL AB 2024-05-08 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214019-001 DAPSONE 7.5% GEL / TOPICAL AB 2024-05-08 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1538 DAPSONE GEL [ZYDUS LIFESCIENCES LIMITED] 1 Current NDC, 6 package rows 20240511_8b63b653-0507-4f95-9bfa-70fd071e15a6.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 · 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 70771-1538-2 70771153802 1 BOTTLE, PUMP in 1 CARTON (70771-1538-2) / 30 g in 1 BOTTLE, PUMP 2024-05-10 No No Current 70771-1538-3 70771153803 1 BOTTLE, PUMP in 1 CARTON (70771-1538-3) / 60 g in 1 BOTTLE, PUMP 2024-05-10 No No Current 70771-1538-8 70771153808 1 BOTTLE, PUMP in 1 CARTON (70771-1538-8) / 90 g in 1 BOTTLE, PUMP 2024-05-10 No No Current