Azithromycin Monohydrate

Product NDC: 65162-758
Requested package NDC: 65162-758-83
11-digit product format: 651620758
Labeler code: 65162
Product ID: 65162-758_82138e21-e33f-497a-9c22-a7ef292af8a1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin Monohydrate
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA205666
Marketing category: ANDA
Marketing start: 2018-07-23
Marketing end: 0000-00-00
Substance: AZITHROMYCIN MONOHYDRATE
Active strength: 200 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	65162-758	65162-758-83	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205666-001	AZITHROMYCIN	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL			2018-07-19
A205666-002	AZITHROMYCIN	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL			2018-07-19

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	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2018-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2018-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2018-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2018-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A205666-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205666-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205666-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205666-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205666-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205666-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205666-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205666-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205666-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205666-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205666-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205666-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205666-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205666-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205666-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205666-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205666-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205666-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205666-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205666-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205666-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205666-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205666-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205666-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205666-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205666-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205666-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205666-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205666-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205666-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205666-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205666-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205666-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205666-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205666-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205666-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205666-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205666-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205666-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205666-002	AB	1	`5aa47cf7b7d7…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-758	AZITHROMYCIN MONOHYDRATE POWDER, FOR SUSPENSION [AMNEAL PHARMACEUTICALS LLC]	21	Legacy NDC	20241025_ca7aa2f0-514c-43bc-9bc2-021b4f059c5b.zip

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
65162-758-83	65162075883	1 BOTTLE in 1 CARTON (65162-758-83) > 15 mL in 1 BOTTLE	1 bottle	2018-07-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azithromycin Monohydrate	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals of New York, LLC	2022-07-23	HUMAN PRESCRIPTION DRUG LABEL	21