Home NDC 70954-135 DAPSONE
Product NDC 70954-135
11-digit product format 709540135
Labeler code 70954
Product ID 70954-135_846ff8b6-d395-4e67-98ea-9dbfd688b97e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dapsone
Dosage form TABLET
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA206505
Marketing category ANDA
Marketing start 2018-01-15
Substance DAPSONE
Active strength 25 mg/1
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 · 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.
Additional Listing Data#
Finished product Yes
Brand name base DAPSONE
Listing expiration 2026-12-31 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70954-135-10 DAPSONE 30 in 1 BOTTLE TABLET 30 3 70954-135-20 DAPSONE 100 in 1 BOTTLE TABLET 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-135 DAPSONE TABLET [ANI PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20250429_57a47368-d1f6-4d61-a2ee-c5f1fe7ff690.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70954-135-10 70954013510 30 TABLET in 1 BOTTLE (70954-135-10) 30 tablet 2018-01-15 0000-00-00 No No Current 70954-135-20 70954013520 100 TABLET in 1 BOTTLE (70954-135-20) 100 tablet 2018-01-15 0000-00-00 No No Current