Home NDC 72162-2297 Azelaic Acid Gel
Product NDC 72162-2297
11-digit product format 721622297
Labeler code 72162
Product ID 72162-2297_92d67e5a-c010-4edf-bce7-858c8a4cc818
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azelaic Acid
Dosage form GEL
Route TOPICAL
Labeler Bryant Ranch Prepack
Application ANDA208724
Marketing category ANDA
Marketing start 2023-11-30
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 2027-12-31
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 A208724-001 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 A208724-001 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 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208724-001 AZELAIC ACID 15% GEL / TOPICAL AB 2018-11-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208724-001 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 Gel
Listing expiration 2027-12-31 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 72162-2297-2 Azelaic Acid Gel 1 in 1 CARTON GEL 1 103 72162-2297-2 Azelaic Acid Gel 50 g in 1 TUBE GEL 50 103
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-2297 AZELAIC ACID GEL (AZELAIC ACID) GEL [BRYANT RANCH PREPACK] 101 Current NDC, 2 package rows 20241122_9c151fc7-cb0b-4931-9c1b-0c29f46ac21f.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 Sample Exclude flag Status 72162-2297-2 72162229702 1 TUBE in 1 CARTON (72162-2297-2) / 50 g in 1 TUBE 1 tube 2023-11-30 No No Current