Azithromycin Dihydrate

Product NDC: 68071-2775
11-digit product format: 680712775
Labeler code: 68071
Product ID: 68071-2775_e845be92-8263-2844-e053-2a95a90aac3a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin Dihydrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmceuticals,Inc.
Application: ANDA208249
Marketing category: ANDA
Marketing start: 2019-07-01
Marketing end: 0000-00-00
Substance: AZITHROMYCIN DIHYDRATE
Active strength: 500 mg/1
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68071-2775		I	Inactivated by FDA	2026-08-03
excluded package	package	68071-2775	68071-2775-2	I	Inactivated by FDA	2026-08-03
excluded package	package	68071-2775	68071-2775-6	I	Inactivated by FDA	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 · 27 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	68071-2775-6	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2775-2	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	68071-2775-6	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2775-2	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	68071-2775-6	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2775-2	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	68071-2775-6	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2775-2	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	68071-2775-6	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2775-2	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	68071-2775-6	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2775-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2775-6	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2775-2	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2775-6	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2775-2	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2775-6	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2775-2	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A208249-001	AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB		2018-10-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A208249-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208249-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-10-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208249-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208249-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208249-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208249-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208249-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208249-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208249-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208249-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208249-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208249-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208249-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208249-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208249-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208249-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208249-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208249-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208249-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208249-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208249-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208249-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208249-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208249-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208249-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208249-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208249-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208249-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208249-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208249-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208249-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208249-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208249-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208249-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208249-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208249-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208249-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208249-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208249-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208249-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208249-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208249-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401	Product name	9	20200616
a2cbe82e-b432-4f71-954b-75e9214e8567	Product name	3	20200612
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
371533fa-efb3-4c48-b5e4-60179db407f3	Product name	3	20190124
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2775-2	2025-01-30	C162847	48780-1	2cef2736-a875-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
68071-2775-6	2025-01-30	C162847	48780-1	2cef2736-a875-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2775-2	Azithromycin Dihydrate	2 in 1 BOTTLE	TABLET, FILM COATED	2		2
68071-2775-6	Azithromycin Dihydrate	6 in 1 BOTTLE	TABLET, FILM COATED	6		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2775	AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [NUCARE PHARMCEUTICALS,INC.]	2	Legacy NDC, 2 package rows	20220911_e2ad6eff-97ff-135a-e053-2a95a90afed5.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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	NuCare Pharmaceuticals,Inc.	21c67de0-3a4e-caab-e063-6394a90ae3cd	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	PD-Rx Pharmaceuticals, Inc.	0c926669-62b2-4ad3-8289-173c5818a9c1	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Bryant Ranch Prepack	7d78cd8e-0c63-46d6-b018-939fcbbe42a6	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	REMEDYREPACK INC.	7711e846-0bb3-486c-8511-f445e264cd98	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Precision Dose, Inc.	3962bc34-8236-4ac1-8ffd-2edbd430c3eb	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	REMEDYREPACK INC.	c7ed6985-1d1d-48af-9df8-64b12821789e	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249
AZITHROMYCIN DIHYDRATE	AZITHROMYCIN DIHYDRATE	DIRECT RX	a6426d5f-5518-3c69-e053-2995a90af50f	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	A-S Medication Solutions	de5b0c2b-9a7d-46e9-8169-4100442efa9b	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Sportpharm LLC	11446677-a3dc-40cb-897d-7a9851b8c89c	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Preferred Pharmaceuticals Inc.	3b90572c-cc24-49f0-baaf-09022a2f9a00	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Health Department, Oklahoma State	4747c5d8-4831-c725-e063-6394a90a4fda	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Redpharm Drug	2fd1f4b5-6c32-3075-e063-6294a90a0d4b	2025-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Coupler LLC	4196e616-bdd8-9e88-e063-6394a90ac81d	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	TAGI Pharma, Inc.	41e2163b-af61-4323-8b9c-2d44fc122fd9	2025-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Advanced Rx of Tennessee, LLC	f1755cf3-bf7f-be40-e053-2a95a90a8536	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Proficient Rx LP	bb97a057-2537-41ae-b50c-a80605039c30	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	A-S Medication Solutions	fcf098d5-dfd5-4a0d-81f7-6afa1a203a27	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	A-S Medication Solutions	b4c05e22-4a54-4948-abf8-8a479d465d30	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Proficient Rx LP	edecf20d-c681-418b-9c47-02fb32d2b3c0	2024-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	A-S Medication Solutions	0f36ba37-a742-41c1-ad2d-b890a1d49c55	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208249 application number: ANDA208249

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5FD1131I7S	AZITHROMYCIN DIHYDRATE	117772-70-0	AZITHROMYCIN DIHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
248656	azithromycin 500 MG Oral Tablet	PSN	e2ad6eff-97ff-135a-e053-2a95a90afed5	2
248656	azithromycin 500 MG Oral Tablet	SCD	e2ad6eff-97ff-135a-e053-2a95a90afed5	2
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	e2ad6eff-97ff-135a-e053-2a95a90afed5	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2775-2	68071277502	2 TABLET, FILM COATED in 1 BOTTLE (68071-2775-2)	2022-06-30	0000-00-00	No	No	Current
68071-2775-6	68071277506	6 TABLET, FILM COATED in 1 BOTTLE (68071-2775-6)	2022-06-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azithromycin Dihydrate	NuCare Pharmceuticals,Inc. \| NuCare Pharmaceuticals,Inc.	2022-09-09	HUMAN PRESCRIPTION DRUG LABEL	2