Home NDC 68462-626 azelaic acid
Product NDC 68462-626
11-digit product format 684620626
Labeler code 68462
Product ID 68462-626_28cca0c1-2f38-4fa2-8aaf-d3c8978b0fc6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name azelaic acid
Dosage form GEL
Route TOPICAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA204637
Marketing category ANDA
Marketing start 2018-11-19
Substance AZELAIC ACID
Active strength .15 g/g
Pharmacologic classes Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]
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 A204637-001 AZELAIC ACID AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204637-001 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 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204637-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 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 azelaic acid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZELAIC ACID .15 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F2VW3D43YT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1041518 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 68462-626-52 azelaic acid 1 in 1 CARTON GEL 1 5 68462-626-52 azelaic acid 50 g in 1 TUBE GEL 50 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-626 AZELAIC ACID GEL [GLENMARK PHARMACEUTICALS INC., USA] 5 Current NDC, Legacy NDC, 2 package rows 20240104_0b5ab22e-c78a-4429-9a76-a4ba2d11fcde.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 68462-626-52 68462062652 1 TUBE in 1 CARTON (68462-626-52) / 50 g in 1 TUBE 1 tube 2018-11-19 0000-00-00 No No Current