Home NDC 0904-7019-46 DAPSONE
Product NDC 0904-7019
Requested package NDC 0904-7019-46
11-digit product format 009047019
Labeler code 0904
Product ID 0904-7019_6ea0a297-f19b-4ae3-8fe3-f1ecee36302c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dapsone
Dosage form TABLET
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA206505
Marketing category ANDA
Marketing start 2018-01-15
Marketing end 0000-00-00
Substance DAPSONE
Active strength 25 mg/1
Pharmacologic classes Sulfone [EPC],Sulfones [CS]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A206505-001 DAPSONE DAPSONE 25MG TABLET / ORAL AB 2016-12-01 A206505-002 DAPSONE DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01
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 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206505-002 DAPSONE 100MG TABLET / ORAL AB RS 2016-12-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206505-002 DAPSONE 100MG TABLET / ORAL AB 2016-12-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206505-002 DAPSONE 100MG TABLET / ORAL AB 2016-12-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206505-002 DAPSONE 100MG TABLET / ORAL AB 2016-12-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206505-002 DAPSONE 100MG TABLET / ORAL AB 2016-12-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206505-002 DAPSONE 100MG TABLET / ORAL AB 2016-12-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206505-001 DAPSONE 25MG TABLET / ORAL AB 2016-12-01 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A206505-002 DAPSONE 100MG TABLET / ORAL AB 2016-12-01 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DAPSONE DAPSONE ANI Pharmaceuticals, Inc. 57a47368-d1f6-4d61-a2ee-c5f1fe7ff690 2025-02-11 Warnings, Adverse reactions Exact identifier application applno (ANDA): 206505 application number: ANDA206505
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-7019-46 00904701946 30 TABLET in 1 BOTTLE (0904-7019-46) 30 tablet 2018-01-15 0000-00-00 No No Current