Home NDC 0378-4830 Dapsone
Product NDC 0378-4830
11-digit product format 003784830
Labeler code 0378
Product ID 0378-4830_b9643f21-be86-4829-a8dc-a29af2e7242c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dapsone
Dosage form GEL
Route TOPICAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA213847
Marketing category ANDA
Marketing start 2022-05-20
Marketing end 2027-05-31
Substance DAPSONE
Active strength 75 mg/g
Pharmacologic classes Sulfone [EPC], Sulfones [CS]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A213847-001 DAPSONE DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213847-001 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.
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 2026-10-15 13:18:30 2026-09 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213847-001 DAPSONE 7.5% GEL / TOPICAL AB 2022-02-04 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Dapsone Active Ingredients# Ingredient, Strength table Ingredient Strength DAPSONE 75 mg/g
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0378-4830-60 Dapsone 60 g in 1 BOTTLE, PUMP GEL 60 2 0378-4830-60 Dapsone 1 in 1 CARTON GEL 1 2 0378-4830-90 Dapsone 90 g in 1 BOTTLE, PUMP GEL 90 2 0378-4830-90 Dapsone 1 in 1 CARTON GEL 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-4830 DAPSONE GEL [MYLAN PHARMACEUTICALS INC.] 2 Current NDC, Legacy NDC, 4 package rows 20240731_e04da0a1-d02a-487d-a931-a31034738fdd.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0378-4830-60 00378483060 1 BOTTLE, PUMP in 1 CARTON (0378-4830-60) / 60 g in 1 BOTTLE, PUMP 2022-05-20 2027-05-31 No No Current 0378-4830-90 00378483090 1 BOTTLE, PUMP in 1 CARTON (0378-4830-90) / 90 g in 1 BOTTLE, PUMP 2022-05-20 2027-05-31 No No Current