Azithromycin

Product NDC: 68788-7307
Requested package NDC: 68788-7307-3
11-digit product format: 687887307
Labeler code: 68788
Product ID: 68788-7307_6dcde61a-d0cc-4be9-bb91-82373a1ead94
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA211147
Marketing category: ANDA
Marketing start: 2020-02-12
Marketing end: 0000-00-00
Substance: AZITHROMYCIN DIHYDRATE
Active strength: 200 mg/5mL
Pharmacologic classes: Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	68788-7307	68788-7307-3	D	Discontinued by firm		2026-08-10

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 · 12 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211147-001	AZITHROMYCIN	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2018-07-31
A211147-002	AZITHROMYCIN	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2018-07-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A211147-001	AB
A211147-002	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 3 · 82 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	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A211147-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211147-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211147-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211147-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211147-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211147-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211147-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211147-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211147-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211147-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211147-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211147-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211147-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211147-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211147-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211147-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211147-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211147-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211147-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211147-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211147-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211147-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211147-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211147-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211147-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211147-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211147-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211147-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211147-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211147-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211147-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211147-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211147-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211147-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211147-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211147-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211147-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211147-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211147-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211147-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7307-3	ML - Milliliter	68788-7307	cdb42197-ac04-41c8-8691-74701ab245d7	1	2020-04-20

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	a1c96531-bbd2-4dc5-8eeb-3f0276cd0956	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211147 application number: ANDA211147
Azithromycin	AZITHROMYCIN	Redpharm Drug	3745a0b0-7855-69eb-e063-6294a90ab6a8	2025-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211147 application number: ANDA211147
Azithromycin	AZITHROMYCIN	Zydus Lifesciences Limited	0b63649d-558c-4250-90ee-af6e1e5c6d2c	2025-01-09		Exact identifier application applno (ANDA): 211147 application number: ANDA211147
Azithromycin	AZITHROMYCIN	Zydus Pharmaceuticals USA Inc.	99e5bd22-a721-4e2e-a46c-d61a53c25c3d	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211147 application number: ANDA211147
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	826f9c07-8eb9-a128-e053-2991aa0ad654	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211147 application number: ANDA211147
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	5ed68b5a-4093-49f1-871b-7b0da5f7be2d	2023-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211147 application number: ANDA211147
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	22a2bdcb-3012-42fb-ac66-d1d879100940	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211147 application number: ANDA211147
Azithromycin	AZITHROMYCIN	Proficient Rx LP	33140df5-420d-469f-b6c8-121e952a5cb6	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211147 application number: ANDA211147

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
68788-7307-3	68788730703	1 BOTTLE in 1 CARTON (68788-7307-3) > 30 mL in 1 BOTTLE	1 bottle	2020-02-12	0000-00-00	No	No	Current