Azithromycin

Product NDC: 55695-002
11-digit product format: 556950002
Labeler code: 55695
Product ID: 55695-002_1287e725-48d5-e23e-e063-6394a90a96ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: STATE HEALTH SERVICES, TEXAS DEPARTMENT OF
Application: ANDA065246
Marketing category: ANDA
Marketing start: 2010-12-28
Substance: AZITHROMYCIN MONOHYDRATE
Active strength: 100 mg/5mL
Pharmacologic classes: Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A065246-001	AZITHROMYCIN	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2006-07-05
A065246-002	AZITHROMYCIN	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2006-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065246-001	AB
A065246-002	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	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`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	A065246-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065246-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065246-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065246-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065246-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065246-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065246-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065246-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065246-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065246-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065246-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065246-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065246-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065246-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065246-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065246-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065246-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065246-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065246-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065246-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065246-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065246-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065246-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065246-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065246-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065246-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065246-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065246-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065246-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065246-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065246-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065246-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065246-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065246-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065246-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065246-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065246-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065246-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065246-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065246-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Azithromycin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZITHROMYCIN MONOHYDRATE	100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JTE4MNN1MD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
141963	Internal RxNorm lookup
308459	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2b821631-0df2-0fb2-e054-00144ff8d46c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401	Product name	9	20200616
a2cbe82e-b432-4f71-954b-75e9214e8567	Product name	3	20200612
371533fa-efb3-4c48-b5e4-60179db407f3	Product name	3	20190124

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55695-002-00	2024-02-29	C162847	48780-1	1030e365-5674-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use azithromycin for oral suspension USP safely and effectively. See full prescribing information for azithromycin for oral suspension USP. AZITHROMYCIN for oral suspension USP for oral use Initial U.S. Approval: 1991
55695-002-00	2024-01-30	C162847	48780-1	1030e365-5674-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use azithromycin for oral suspension USP safely and effectively. See full prescribing information for azithromycin for oral suspension USP. AZITHROMYCIN for oral suspension USP 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
55695-002-00	Azithromycin	15 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	15		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55695-002	AZITHROMYCIN POWDER, FOR SUSPENSION [STATE HEALTH SERVICES, TEXAS DEPARTMENT OF]	4	Current NDC, Legacy NDC, 1 package rows	20240302_2b821631-0df2-0fb2-e054-00144ff8d46c.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	ac327054-21ab-401c-a27a-48259db18f89	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065246 application number: ANDA065246
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	f97d2e7e-ccfd-4f04-85ba-549b37f6aa7b	2024-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065246 application number: ANDA065246
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	549cdd0a-da79-23b8-e054-00144ff8d46c	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065246 application number: ANDA065246
Azithromycin	AZITHROMYCIN	Proficient Rx LP	44134421-cb0b-4e85-a3c8-d58bdb476fad	2024-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065246 application number: ANDA065246
Azithromycin	AZITHROMYCIN	STATE HEALTH SERVICES, TEXAS DEPARTMENT OF	2b821631-0df2-0fb2-e054-00144ff8d46c	2024-02-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065246 application number: ANDA065246 ndc (product): 55695-002
Azithromycin	AZITHROMYCIN	Teva Pharmaceuticals USA, Inc.	3209b147-11ce-4eeb-8427-5f8e6fb2c83d	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065246 application number: ANDA065246

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308459	azithromycin 100 MG in 5 mL Oral Suspension	PSN	2b821631-0df2-0fb2-e054-00144ff8d46c	4
141963	azithromycin 200 MG in 5 mL Oral Suspension	PSN	2b821631-0df2-0fb2-e054-00144ff8d46c	4
308459	azithromycin 20 MG/ML Oral Suspension	SCD	2b821631-0df2-0fb2-e054-00144ff8d46c	4
141963	azithromycin 40 MG/ML Oral Suspension	SCD	2b821631-0df2-0fb2-e054-00144ff8d46c	4
308459	azithromycin 100 MG per 5 ML Oral Suspension	SY	2b821631-0df2-0fb2-e054-00144ff8d46c	4
141963	azithromycin 1200 MG per 30 ML Oral Suspension	SY	2b821631-0df2-0fb2-e054-00144ff8d46c	4
141963	azithromycin 200 MG per 5 ML Oral Suspension	SY	2b821631-0df2-0fb2-e054-00144ff8d46c	4
141963	azithromycin 600 MG per 15 ML Oral Suspension	SY	2b821631-0df2-0fb2-e054-00144ff8d46c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55695-002-00	55695000200	15 mL in 1 BOTTLE (55695-002-00)	15 ml	2010-12-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azithromycin	STATE HEALTH SERVICES, TEXAS DEPARTMENT OF	2024-02-29	HUMAN PRESCRIPTION DRUG LABEL	4