Home NDC 16110-869 AZELEX
Product NDC 16110-869
11-digit product format 161100869
Labeler code 16110
Product ID 16110-869_ae821f0c-ec53-4612-a505-e1aa9d73a158
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name azelaic acid
Dosage form CREAM
Route CUTANEOUS
Labeler Almirall, LLC
Application NDA020428
Marketing category NDA
Marketing start 2018-09-24
Substance AZELAIC ACID
Active strength .2 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 N020428-001 AZELEX AZELAIC ACID 20% CREAM / TOPICAL RLD, RS 1995-09-13
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 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020428-001 AZELEX 20% CREAM / TOPICAL RLD, RS 1995-09-13 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base AZELEX
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZELAIC ACID .2 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1041520 Internal RxNorm lookup 1043753 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 16110-869 AZELEX (AZELAIC ACID) CREAM [ALMIRALL, LLC] 6 Current NDC, Legacy NDC, 4 package rows 20240308_ebdfcaf7-b5d6-47e1-be87-ccaba4b97e75.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 16110-869-30 16110086930 1 TUBE in 1 CARTON (16110-869-30) / 30 g in 1 TUBE 1 tube 2019-07-12 0000-00-00 No No Current 16110-869-50 16110086950 1 TUBE in 1 CARTON (16110-869-50) / 50 g in 1 TUBE 1 tube 2019-07-12 0000-00-00 No No Current