Home NDC 51672-1389 Azelaic Acid
Product NDC 51672-1389
11-digit product format 516721389
Labeler code 51672
Product ID 51672-1389_3cf92843-22fd-ba71-e063-6294a90a1fc6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azelaic Acid
Dosage form GEL
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA210549
Marketing category ANDA
Marketing start 2019-08-23
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 1 .
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 A210549-001 AZELAIC ACID AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210549-001 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 2026-02-19 14:30 UTC 2026-02 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210549-001 AZELAIC ACID 15% GEL / TOPICAL AB 2019-08-23 a50c72e98297…
Observed Orange Book normalized TE history# 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 51672-1389-3 Azelaic Acid 50 g in 1 TUBE GEL 50 5 51672-1389-3 Azelaic Acid 1 in 1 CARTON GEL 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1389 AZELAIC ACID GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3 Current NDC, Legacy NDC, 2 package rows 20220129_d4e9e95d-1ebd-44df-a91e-59819715659c.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 51672-1389-3 51672138903 1 TUBE in 1 CARTON (51672-1389-3) / 50 g in 1 TUBE 1 tube 2019-08-23 0000-00-00 No No Current