Home NDC 17478-307-03 AzaSITE
Product NDC 17478-307
Requested package NDC 17478-307-03
11-digit product format 174780307
Labeler code 17478
Product ID 17478-307_1a5cc030-9de6-4918-a165-ccad89d6f2ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin Monohydrate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Akorn
Application NDA050810
Marketing category NDA
Marketing start 2014-05-14
Marketing end 0000-00-00
Substance AZITHROMYCIN MONOHYDRATE
Active strength 10 mg/mL
Pharmacologic classes Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 N050810-001 AZASITE AZITHROMYCIN 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050810-001 AZASITE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-04-27 cb3db0bc1861…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N050810-001 6239113 2019-03-31 U-709 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050810-001 6569443 2019-03-31 U-709 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050810-001 7056893 2019-03-31 U-709 Drug product 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N050810-001 6239113 2019-03-31 U-709 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050810-001 6569443 2019-03-31 U-709 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050810-001 7056893 2019-03-31 U-709 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050810-001 6239113 2019-03-31 U-709 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N050810-001 6569443 2019-03-31 U-709 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N050810-001 7056893 2019-03-31 U-709 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050810-001 6239113 2019-03-31 U-709 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N050810-001 6569443 2019-03-31 U-709 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N050810-001 7056893 2019-03-31 U-709 Drug product ea99ee380514…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17478-307-01 AzaSITE 1 in 1 CARTON SOLUTION/ DROPS 1 6 17478-307-01 AzaSITE 1 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 1 6 17478-307-03 AzaSITE 2.5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 2.5 6 17478-307-03 AzaSITE 1 in 1 CARTON SOLUTION/ DROPS 1 6 17478-307-04 AzaSITE 2.5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 2.5 6 17478-307-04 AzaSITE 1 in 1 CARTON SOLUTION/ DROPS 1 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Azithromycin Monohydrate ACTIVE INGREDIENT JTE4MNN1MD AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] 2 Azithromycin Anhydrous ACTIVE MOIETY J2KLZ20U1M AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] 2 Benzalkonium Chloride INACTIVE INGREDIENT F5UM2KM3W7 AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] 2 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] 2 Edetate Disodium INACTIVE INGREDIENT 7FLD91C86K AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] 2 Mannitol INACTIVE INGREDIENT 3OWL53L36A AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] 2 Poloxamer 407 INACTIVE INGREDIENT TUF2IVW3M2 AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] 2 Polycarbophil INACTIVE INGREDIENT W25LM17A4W AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] 2 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] 2 Sodium Citrate INACTIVE INGREDIENT 1Q73Q2JULR AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] 2 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17478-307 AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN] 6 Legacy NDC, 6 package rows 20220503_14ae4c07-b042-452a-b069-2b41bc646e04.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AZASITE AZITHROMYCIN MONOHYDRATE Thea Pharma Inc. 0c5d6f5e-18ea-436f-8c62-bbaf66effe3d 2024-07-25 Warnings, Adverse reactions Exact identifier application applno (NDA): 050810 application number: NDA050810
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 17478-307-03 17478030703 1 BOTTLE, DROPPER in 1 CARTON (17478-307-03) > 2.5 mL in 1 BOTTLE, DROPPER 2014-05-14 0000-00-00 No No Current