Home NDC 60758-670 DAPSONE
Product NDC 60758-670
11-digit product format 607580670
Labeler code 60758
Product ID 60758-670_41079403-219e-4194-90e8-3b9b83dcf298
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dapsone
Dosage form GEL
Route TOPICAL
Labeler Pacific Pharma, Inc.
Application NDA021794
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2017-10-18
Substance DAPSONE
Active strength 50 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 42 .
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 N021794-001 ACZONE DAPSONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021794-001 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.
Product history page 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 50 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 607295 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 60758-670 DAPSONE GEL [PACIFIC PHARMA, INC.] 5 Current NDC, Legacy NDC, 6 package rows 20230425_8dbe1a41-6d9d-414f-aa9c-09bd95857e2a.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 Units Marketing start Marketing end Sample Exclude flag Status 60758-670-30 60758067030 1 TUBE in 1 CARTON (60758-670-30) / 30 g in 1 TUBE 1 tube 2017-10-18 0000-00-00 No No Current 60758-670-60 60758067060 1 TUBE in 1 CARTON (60758-670-60) / 60 g in 1 TUBE 1 tube 2017-10-18 0000-00-00 No No Current 60758-670-90 60758067090 1 TUBE in 1 CARTON (60758-670-90) / 90 g in 1 TUBE 1 tube 2017-10-18 0000-00-00 No No Current