Home NDC 85185-105 Dapsone 100mg
Product NDC 85185-105
11-digit product format 851850105
Labeler code 85185
Product ID 85185-105_50209cd1-afc6-53f4-e063-6394a90af9cf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dapsone 100mg
Dosage form TABLET
Route ORAL
Labeler Solis Pharmaceuticals Inc.
Application ANDA203887
Marketing category ANDA
Marketing start 2016-05-09
Substance DAPSONE
Active strength 100 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 1 .
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 A203887-001 DAPSONE DAPSONE 25MG TABLET / ORAL AB 2016-05-06 A203887-002 DAPSONE DAPSONE 100MG TABLET / ORAL AB 2016-05-06
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.
Product history page 1 of 3 · 82 observed 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 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203887-001 DAPSONE 25MG TABLET / ORAL AB 2016-05-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203887-002 DAPSONE 100MG TABLET / ORAL AB 2016-05-06 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Dapsone 100mg
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DAPSONE 100 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85185-105-01 Dapsone 100mg 30 in 1 BOTTLE TABLET 30 1 85185-105-02 Dapsone 100mg 100 in 1 BOTTLE TABLET 100 1
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 Units Marketing start Sample Exclude flag Status 85185-105-01 85185010501 30 TABLET in 1 BOTTLE (85185-105-01) 30 tablet 2016-05-09 No No Current 85185-105-02 85185010502 100 TABLET in 1 BOTTLE (85185-105-02) 100 tablet 2016-05-09 No No Current