Azithromycin

Product NDC: 71205-216
11-digit product format: 712050216
Labeler code: 71205
Product ID: 71205-216_476af655-9fb8-4253-a569-fb3295680838
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA211147
Marketing category: ANDA
Marketing start: 2018-08-06
Substance: AZITHROMYCIN DIHYDRATE
Active strength: 200 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
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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZITHROMYCIN DIHYDRATE	200 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5FD1131I7S	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
141963	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
33140df5-420d-469f-b6c8-121e952a5cb6	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71205-216-30	Azithromycin	30 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	30		3
71205-216-30	Azithromycin	1 in 1 CARTON	POWDER, FOR SUSPENSION	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-216-30	ML - Milliliter	71205-216	a191e37c-3944-4e8e-a695-eb26a56355dd	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-216	AZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 2 package rows	20221110_33140df5-420d-469f-b6c8-121e952a5cb6.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 · 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 ndc (product): 71205-216

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5FD1131I7S	AZITHROMYCIN DIHYDRATE	117772-70-0	AZITHROMYCIN DIHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
141963	azithromycin 200 MG in 5 mL Oral Suspension	PSN	33140df5-420d-469f-b6c8-121e952a5cb6	3
141963	azithromycin 40 MG/ML Oral Suspension	SCD	33140df5-420d-469f-b6c8-121e952a5cb6	3
141963	azithromycin 1200 MG per 30 ML Oral Suspension	SY	33140df5-420d-469f-b6c8-121e952a5cb6	3
141963	azithromycin 200 MG per 5 ML Oral Suspension	SY	33140df5-420d-469f-b6c8-121e952a5cb6	3
141963	azithromycin 600 MG per 15 ML Oral Suspension	SY	33140df5-420d-469f-b6c8-121e952a5cb6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-216-30	71205021630	1 BOTTLE in 1 CARTON (71205-216-30) / 30 mL in 1 BOTTLE	1 bottle	2019-02-01	0000-00-00	No	No	Current