AzaSITE

Product NDC: 17478-307
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17478-307		I	Inactivated by FDA	2026-08-03
excluded package	package	17478-307	17478-307-01	D	Discontinued by firm	2026-08-03
excluded package	package	17478-307	17478-307-03	I	Inactivated by FDA	2026-08-03
excluded package	package	17478-307	17478-307-04	D	Discontinued by firm	2026-08-03

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 · 54 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-307-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-307-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-307-03	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-307-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-307-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-307-03	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-307-04	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-307-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-307-03	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-307-04	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-307-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-307-03	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-307-04	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-307-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-307-03	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-307-04	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-307-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-307-03	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17478-307-04	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17478-307-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17478-307-03	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17478-307-04	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17478-307-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17478-307-03	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17478-307-04	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17478-307-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17478-307-03	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17478-307-04	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17478-307-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17478-307-03	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17478-307-04	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17478-307-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17478-307-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-307-04	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-307-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-307-03	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17478-307-03	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17478-307-03	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17478-307-03	I	Inactivated by FDA	`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	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	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#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401	Product name	9	20200616
a2cbe82e-b432-4f71-954b-75e9214e8567	Product name	3	20200612
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
371533fa-efb3-4c48-b5e4-60179db407f3	Product name	3	20190124
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-307-01	2024-01-30	C162847	48780-1	1030e365-61d2-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use AzaSite safely and effectively. See full prescribing information for AzaSite. AzaSite ® (azithromycin ophthalmic solution) 1% Sterile topical ophthalmic drops Initial U.S. Approval: 2007
17478-307-03	2024-01-30	C162847	48780-1	1030e365-61d2-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use AzaSite safely and effectively. See full prescribing information for AzaSite. AzaSite ® (azithromycin ophthalmic solution) 1% Sterile topical ophthalmic drops Initial U.S. Approval: 2007
17478-307-04	2024-01-30	C162847	48780-1	1030e365-61d2-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use AzaSite safely and effectively. See full prescribing information for AzaSite. AzaSite ® (azithromycin ophthalmic solution) 1% Sterile topical ophthalmic drops Initial U.S. Approval: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-307-03	ML - Milliliter	17478-307	76954fc9-a779-4a12-b1aa-87756c6971a4	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JTE4MNN1MD	AZITHROMYCIN MONOHYDRATE	121470-24-4	AZITHROMYCIN MONOHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
706872	AzaSite 1 % Ophthalmic Solution	PSN	14ae4c07-b042-452a-b069-2b41bc646e04	6
706868	azithromycin 1 % Ophthalmic Solution	PSN	14ae4c07-b042-452a-b069-2b41bc646e04	6
706872	azithromycin 10 MG/ML Ophthalmic Solution [AzaSite]	SBD	14ae4c07-b042-452a-b069-2b41bc646e04	6
706868	azithromycin 10 MG/ML Ophthalmic Solution	SCD	14ae4c07-b042-452a-b069-2b41bc646e04	6
706872	AzaSite 1 % Ophthalmic Solution	SY	14ae4c07-b042-452a-b069-2b41bc646e04	6
706872	AzaSite 10 MG/ML Ophthalmic Solution	SY	14ae4c07-b042-452a-b069-2b41bc646e04	6
706868	azithromycin (as azithromycin monohydrate) 10 MG/ML Ophthalmic Solution	SY	14ae4c07-b042-452a-b069-2b41bc646e04	6
706868	azithromycin 1 % Ophthalmic Solution	SY	14ae4c07-b042-452a-b069-2b41bc646e04	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-307-01	17478030701	1 BOTTLE, DROPPER in 1 CARTON (17478-307-01) > 1 mL in 1 BOTTLE, DROPPER	2014-05-14	0000-00-00	No	No	Current
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
17478-307-04	17478030704	1 BOTTLE, DROPPER in 1 CARTON (17478-307-04) > 2.5 mL in 1 BOTTLE, DROPPER	2014-05-14	0000-00-00	No	No	Current