AZASITE

Product NDC: 82584-307
11-digit product format: 825840307
Labeler code: 82584
Product ID: 82584-307_1e292167-581f-b1db-e063-6394a90ae8a1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azithromycin monohydrate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Thea Pharma Inc.
Application: NDA050810
Marketing category: NDA
Marketing start: 2022-11-01
Substance: AZITHROMYCIN MONOHYDRATE
Active strength: 10 mg/mL
Pharmacologic classes: Macrolide Antimicrobial [EPC], Macrolides [CS]
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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: AZASITE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZITHROMYCIN MONOHYDRATE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JTE4MNN1MD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
706868	Internal RxNorm lookup
706872	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0c5d6f5e-18ea-436f-8c62-bbaf66effe3d	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
82584-307-02	AZASITE	1 in 1 CARTON	SOLUTION/ DROPS	1	4
82584-307-02	AZASITE	2.5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	2.5	4
82584-307-03	AZASITE	2.5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	2.5	4
82584-307-03	AZASITE	1 in 1 CARTON	SOLUTION/ DROPS	1	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82584-307-03	ML - Milliliter	82584-307	ba259eb2-2b27-467a-bebb-28fb258aa7c3	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82584-307	AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [THEA PHARMA INC.]	4	Current NDC, Legacy NDC, 4 package rows	20240730_0c5d6f5e-18ea-436f-8c62-bbaf66effe3d.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 ndc (product): 82584-307

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	0c5d6f5e-18ea-436f-8c62-bbaf66effe3d	4
706868	azithromycin 1 % Ophthalmic Solution	PSN	0c5d6f5e-18ea-436f-8c62-bbaf66effe3d	4
706872	azithromycin 10 MG/ML Ophthalmic Solution [AzaSite]	SBD	0c5d6f5e-18ea-436f-8c62-bbaf66effe3d	4
706868	azithromycin 10 MG/ML Ophthalmic Solution	SCD	0c5d6f5e-18ea-436f-8c62-bbaf66effe3d	4
706872	AzaSite 1 % Ophthalmic Solution	SY	0c5d6f5e-18ea-436f-8c62-bbaf66effe3d	4
706872	AzaSite 10 MG/ML Ophthalmic Solution	SY	0c5d6f5e-18ea-436f-8c62-bbaf66effe3d	4
706868	azithromycin (as azithromycin monohydrate) 10 MG/ML Ophthalmic Solution	SY	0c5d6f5e-18ea-436f-8c62-bbaf66effe3d	4
706868	azithromycin 1 % Ophthalmic Solution	SY	0c5d6f5e-18ea-436f-8c62-bbaf66effe3d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
82584-307-02	82584030702	1 BOTTLE, DROPPER in 1 CARTON (82584-307-02) / 2.5 mL in 1 BOTTLE, DROPPER	2022-11-01	0000-00-00	Yes	No	Current
82584-307-03	82584030703	1 BOTTLE, DROPPER in 1 CARTON (82584-307-03) / 2.5 mL in 1 BOTTLE, DROPPER	2022-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AZASITE	Thea Pharma Inc. \| Woodstock Sterile Solutions, Inc.	2024-07-25	HUMAN PRESCRIPTION DRUG LABEL	4