Home NDC 64980-566 Dapsone
Product NDC 64980-566
11-digit product format 649800566
Labeler code 64980
Product ID 64980-566_e1aaf1ed-de8a-4c31-85de-68d728c95e86
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dapsone
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA207165
Marketing category ANDA
Marketing start 2022-12-11
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 A207165-001 DAPSONE DAPSONE 100MG TABLET / ORAL AB 2019-05-08 A207165-002 DAPSONE DAPSONE 25MG TABLET / ORAL AB 2023-07-20
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 2 · 61 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 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207165-002 DAPSONE 25MG TABLET / ORAL AB 2023-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207165-002 DAPSONE 25MG TABLET / ORAL AB 2023-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207165-002 DAPSONE 25MG TABLET / ORAL AB 2023-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207165-002 DAPSONE 25MG TABLET / ORAL AB 2023-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207165-002 DAPSONE 25MG TABLET / ORAL AB 2023-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207165-002 DAPSONE 25MG TABLET / ORAL AB 2023-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207165-002 DAPSONE 25MG TABLET / ORAL AB 2023-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207165-002 DAPSONE 25MG TABLET / ORAL AB 2023-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207165-002 DAPSONE 25MG TABLET / ORAL AB 2023-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207165-002 DAPSONE 25MG TABLET / ORAL AB 2023-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207165-002 DAPSONE 25MG TABLET / ORAL AB 2023-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207165-002 DAPSONE 25MG TABLET / ORAL AB 2023-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207165-002 DAPSONE 25MG TABLET / ORAL AB 2023-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207165-002 DAPSONE 25MG TABLET / ORAL AB 2023-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207165-001 DAPSONE 100MG TABLET / ORAL AB 2019-05-08 b00525d2431f…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 61 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Dapsone
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 64980-566-01 Dapsone 100 in 1 BOTTLE TABLET 100 7 64980-566-03 Dapsone 30 in 1 BOTTLE TABLET 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-566 DAPSONE TABLET [RISING PHARMA HOLDINGS, INC.] 5 Current NDC, 2 package rows 20230831_e369b26d-219a-4e23-b8d4-f94048d36acd.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 · 3 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 64980-566-01 64980056601 100 TABLET in 1 BOTTLE (64980-566-01) 100 tablet 2022-12-11 No No Current 64980-566-03 64980056603 30 TABLET in 1 BOTTLE (64980-566-03) 30 tablet 2023-07-12 No No Current