AZITHROMYCIN

Product NDC: 68071-3897
11-digit product format: 680713897
Labeler code: 68071
Product ID: 68071-3897_3f7c742b-a360-bef8-e063-6294a90a93ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azithromycin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA207531
Marketing category: ANDA
Marketing start: 2018-04-10
Substance: AZITHROMYCIN MONOHYDRATE
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
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 · 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	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…`
2022-03-09 01:35 UTC	2022-03	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207531-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207531-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-04-09	`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	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…`
2022-03-09 01:35 UTC	2022-03	A207531-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207531-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207531-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207531-002	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	200 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 · 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
3f7c7421-411d-c04e-e063-6394a90a4aa0	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
68071-3897-2	AZITHROMYCIN	22.5 mL in 1 BOTTLE, PLASTIC	POWDER, FOR SUSPENSION	22.5		1

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 ndc (product): 68071-3897
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

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	3f7c7421-411d-c04e-e063-6394a90a4aa0	1
141963	azithromycin 40 MG/ML Oral Suspension	SCD	3f7c7421-411d-c04e-e063-6394a90a4aa0	1
141963	azithromycin 1200 MG per 30 ML Oral Suspension	SY	3f7c7421-411d-c04e-e063-6394a90a4aa0	1
141963	azithromycin 200 MG per 5 ML Oral Suspension	SY	3f7c7421-411d-c04e-e063-6394a90a4aa0	1
141963	azithromycin 600 MG per 15 ML Oral Suspension	SY	3f7c7421-411d-c04e-e063-6394a90a4aa0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3897-2	68071389702	22.5 mL in 1 BOTTLE, PLASTIC (68071-3897-2)	22.5 ml	2025-09-23	No	No	Current