Azithromycin Dihydrate

Product NDC: 68788-8311
Requested package NDC: 68788-8311-3
11-digit product format: 687888311
Labeler code: 68788
Product ID: 68788-8311_4e3ca491-2729-4250-8475-f2c9be6ba86e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin Dihydrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA208249
Marketing category: ANDA
Marketing start: 2022-12-20
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-8311	68788-8311-3	D	Discontinued by firm		2026-08-03

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8311-3	EA - Each	68788-8311	3a976e69-811e-4a47-a82e-924cbcfa88a9	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8311	AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	3	Legacy NDC	20250207_4e3ca491-2729-4250-8475-f2c9be6ba86e.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8311-3	68788831103	1 BLISTER PACK in 1 CARTON (68788-8311-3) > 3 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2022-12-20	0000-00-00	No	No	Current