AZITHROMYCIN FOR ORAL SUSPENSION

Manufacturer: Zydus Lifesciences Limited
Effective date: 2025-01-09
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 21:22:10

Label at a glance#

ProductAzithromycin

Active ingredientAZITHROMYCIN DIHYDRATE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1422-1

Azithromycin for oral suspension, 300 mg

100 mg/5 mL

Rx only

NDC 70771-1423-2

Azithromycin for oral suspension, 600 mg

200 mg/5 mL

Rx only

NDC 70771-1424-2

Azithromycin for oral suspension, 900 mg

200 mg/5 mL

Rx only

NDC 70771-1425-2

Azithromycin for oral suspension, 1200 mg

200 mg/5 mL

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308459	azithromycin 100 MG in 5 mL Oral Suspension	PSN	5
141963	azithromycin 200 MG in 5 mL Oral Suspension	PSN	5
308459	azithromycin 20 MG/ML Oral Suspension	SCD	5
141963	azithromycin 40 MG/ML Oral Suspension	SCD	5
308459	azithromycin 100 MG per 5 ML Oral Suspension	SY	5
141963	azithromycin 1200 MG per 30 ML Oral Suspension	SY	5
141963	azithromycin 200 MG per 5 ML Oral Suspension	SY	5
141963	azithromycin 600 MG per 15 ML Oral Suspension	SY	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
AZITHROMYCIN ANHYDROUS Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1422-1	Azithromycin	1 in 1 CARTON	POWDER, FOR SUSPENSION	1	5
70771-1422-1	Azithromycin	15 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	15	5
70771-1423-2	Azithromycin	1 in 1 CARTON	POWDER, FOR SUSPENSION	1	5
70771-1423-2	Azithromycin	15 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	15	5
70771-1424-2	Azithromycin	22.5 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	22.5	5
70771-1424-2	Azithromycin	1 in 1 CARTON	POWDER, FOR SUSPENSION	1	5
70771-1425-2	Azithromycin	1 in 1 CARTON	POWDER, FOR SUSPENSION	1	5
70771-1425-2	Azithromycin	30 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	30	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1422	AZITHROMYCIN POWDER, FOR SUSPENSION [ZYDUS LIFESCIENCES LIMITED]	5	Current NDC, Legacy NDC, 2 package rows	20250110_0b63649d-558c-4250-90ee-af6e1e5c6d2c.zip
70771-1423	AZITHROMYCIN POWDER, FOR SUSPENSION [ZYDUS LIFESCIENCES LIMITED]	5	Current NDC, Legacy NDC, 2 package rows	20250110_0b63649d-558c-4250-90ee-af6e1e5c6d2c.zip
70771-1424	AZITHROMYCIN POWDER, FOR SUSPENSION [ZYDUS LIFESCIENCES LIMITED]	5	Current NDC, Legacy NDC, 2 package rows	20250110_0b63649d-558c-4250-90ee-af6e1e5c6d2c.zip
70771-1425	AZITHROMYCIN POWDER, FOR SUSPENSION [ZYDUS LIFESCIENCES LIMITED]	5	Current NDC, Legacy NDC, 2 package rows	20250110_0b63649d-558c-4250-90ee-af6e1e5c6d2c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Azithromycin
AZITHROMYCIN DIHYDRATE
AZITHROMYCIN ANHYDROUS
FD&C RED NO. 40
HYDROXYPROPYL CELLULOSE (90000 WAMW)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS
SUCROSE
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1422	70771-1422-1
70771-1423	70771-1423-2
70771-1424	70771-1424-2
70771-1425	70771-1425-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AZITHROMYCIN DIHYDRATE	5FD1131I7S	ACTIM
FD&C RED NO. 40	WZB9127XOA	IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)	UKE75GEA7F	IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS	SX01TZO3QZ	IACT
SUCROSE	C151H8M554	IACT
XANTHAN GUM	TTV12P4NEE	IACT
AZITHROMYCIN DIHYDRATE	5FD1131I7S	ACTIM
FD&C RED NO. 40	WZB9127XOA	IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)	UKE75GEA7F	IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS	SX01TZO3QZ	IACT
SUCROSE	C151H8M554	IACT
XANTHAN GUM	TTV12P4NEE	IACT
AZITHROMYCIN DIHYDRATE	5FD1131I7S	ACTIM
FD&C RED NO. 40	WZB9127XOA	IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)	UKE75GEA7F	IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS	SX01TZO3QZ	IACT
SUCROSE	C151H8M554	IACT
XANTHAN GUM	TTV12P4NEE	IACT
AZITHROMYCIN DIHYDRATE	5FD1131I7S	ACTIM
FD&C RED NO. 40	WZB9127XOA	IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)	UKE75GEA7F	IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS	SX01TZO3QZ	IACT
SUCROSE	C151H8M554	IACT
XANTHAN GUM	TTV12P4NEE	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 88 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
2026-10-15 13:18:30	2026-09	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211147-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211147-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-31	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A211147-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A211147-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A211147-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211147-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211147-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211147-002	AB	1	`caaa826d4ba7…`
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…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	Zydus Lifesciences Limited	0b63649d-558c-4250-90ee-af6e1e5c6d2c	2025-01-09		Exact identifier ndc (package): 70771-1425-2 ndc (package): 70771-1422-1 ndc (package): 70771-1423-2 ndc (package): 70771-1424-2 ndc (product): 70771-1422 ndc (product): 70771-1424 ndc (product): 70771-1423 ndc (product): 70771-1425 ndc11 (package): 70771142201 ndc11 (package): 70771142502 ndc11 (package): 70771142402 ndc11 (package): 70771142302 spl id: 654b77ea-07ad-4747-ac35-5a2eb41f4588 spl set id: 0b63649d-558c-4250-90ee-af6e1e5c6d2c

Reported adverse events (FAERS/openFDA)#

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