AZITHROMYCIN

Product NDC: 68788-7636
11-digit product format: 687887636
Labeler code: 68788
Product ID: 68788-7636_5c455afb-b5d6-466d-abf8-9ac9b158ceca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AZITHROMYCIN
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA207531
Marketing category: ANDA
Marketing start: 2020-03-10
Marketing end: 0000-00-00
Substance: AZITHROMYCIN MONOHYDRATE
Active strength: 100 mg/5mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68788-7636		D	Discontinued by firm		2026-10-05
excluded package	package	68788-7636	68788-7636-1	D	Discontinued by firm		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A207531-001	AZITHROMYCIN	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2018-04-09
A207531-002	AZITHROMYCIN	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2018-04-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207531-001	AB
A207531-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207531-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207531-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207531-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207531-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207531-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207531-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207531-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207531-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207531-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207531-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207531-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207531-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207531-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207531-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207531-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207531-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207531-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207531-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207531-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207531-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207531-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207531-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207531-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207531-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207531-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207531-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207531-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207531-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207531-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207531-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207531-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207531-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207531-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207531-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207531-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207531-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207531-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207531-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207531-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207531-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7636-1	ML - Milliliter	68788-7636	1da4ea68-df85-4f36-b7d3-9a33a2485709	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7636	AZITHROMYCIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.]	6	Legacy NDC	20250207_3562f797-1458-43ac-b618-26e5414da9db.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AZITHROMYCIN	AZITHROMYCIN	A-S Medication Solutions	76093152-e2d7-4fe1-8568-1f0fec1747c2	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207531 application number: ANDA207531
AZITHROMYCIN	AZITHROMYCIN	Preferred Pharmaceuticals, Inc.	9e4fbd52-43e4-4d87-a136-f4d680a8d0c1	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207531 application number: ANDA207531
AZITHROMYCIN	AZITHROMYCIN	A-S Medication Solutions	405ab07f-7d1d-4552-ad3b-2a03be8e9949	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207531 application number: ANDA207531
AZITHROMYCIN	AZITHROMYCIN	Epic Pharma, LLC	59c4b783-4ff7-4269-969b-58a10e12b12b	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207531 application number: ANDA207531
AZITHROMYCIN	AZITHROMYCIN	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	714f6f55-278a-4fcf-8d4e-2ad9b43623a3	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207531 application number: ANDA207531
AZITHROMYCIN	AZITHROMYCIN	NuCare Pharmaceuticals, Inc.	3f7c7421-411d-c04e-e063-6394a90a4aa0	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207531 application number: ANDA207531
AZITHROMYCIN	AZITHROMYCIN	DirectRx	d564d91e-3039-c120-e053-2995a90ae6db	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207531 application number: ANDA207531
AZITHROMYCIN	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	90a506cd-aae7-a622-e053-2a95a90ad352	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207531 application number: ANDA207531
AZITHROMYCIN	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	82454fb2-e524-ecb8-e053-2991aa0a6e7c	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207531 application number: ANDA207531
AZITHROMYCIN	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	8389c336-25eb-a96f-e053-2a91aa0a0dd8	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207531 application number: ANDA207531
AZITHROMYCIN	AZITHROMYCIN	Proficient Rx LP	e1172805-0930-4fb9-8a2f-e0d6a0430630	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207531 application number: ANDA207531
AZITHROMYCIN	AZITHROMYCIN	Proficient Rx LP	b3761d39-9b79-4908-8b05-a1c91e599998	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207531 application number: ANDA207531

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7636-1	68788763601	15 mL in 1 BOTTLE, PLASTIC (68788-7636-1)	15 ml	2020-03-10	0000-00-00	No	No	Current