Azithromycin

Product NDC: 69452-172
11-digit product format: 694520172
Labeler code: 69452
Product ID: 69452-172_4526a56d-6695-5338-e063-6294a90aa2b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA210001
Marketing category: ANDA
Marketing start: 2019-03-12
Substance: AZITHROMYCIN DIHYDRATE
Active strength: 500 mg/1
Pharmacologic classes: Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished product	product	69452-172		UNFINISHED	Active or certified unfinished drug listing		2026-08-07
unfinished package	package	69452-172	69452-172-99	UNFINISHED	Active or certified unfinished drug listing		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 28 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	69452-172-99	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	69452-172-99	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	69452-172-99	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	69452-172-99	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	69452-172-99	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	69452-172-99	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	69452-172-99	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	69452-172-99	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	69452-172-99	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	69452-172-99	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	69452-172-99	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	69452-172-99	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	69452-172-99	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	69452-172-99	`50b4072663b7…`	`eae3003ed65e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210001-001	AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB		2019-02-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210001-001	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 2 · 41 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	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A210001-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210001-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210001-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210001-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210001-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210001-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210001-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210001-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210001-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210001-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210001-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210001-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210001-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210001-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210001-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210001-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210001-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210001-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210001-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210001-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210001-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210001-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210001-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210001-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210001-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210001-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210001-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210001-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210001-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210001-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210001-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210001-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210001-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210001-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210001-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210001-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210001-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210001-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210001-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210001-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZITHROMYCIN DIHYDRATE	500 mg/1

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
248656	Internal RxNorm lookup
308460	Internal RxNorm lookup
749780	Internal RxNorm lookup
749783	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
859bb02c-a4bc-46fa-9fc9-def1219b5dfb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401	Product name	9	20200616
a2cbe82e-b432-4f71-954b-75e9214e8567	Product name	3	20200612
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
371533fa-efb3-4c48-b5e4-60179db407f3	Product name	3	20190124
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69452-172-13	Azithromycin	30 in 1 BOTTLE	TABLET, FILM COATED	30	7
69452-172-72	Azithromycin	3 in 1 CARTON	TABLET, FILM COATED	3	7
69452-172-72	Azithromycin	3 in 1 BLISTER PACK	TABLET, FILM COATED	3	7
69452-172-74	Azithromycin	1 in 1 CARTON	TABLET, FILM COATED	1	7
69452-172-74	Azithromycin	3 in 1 BLISTER PACK	TABLET, FILM COATED	3	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69452-172-13	EA - Each	69452-172	a8208acb-1c0e-4c24-8b70-3f88492f875f	1	2019-06-19
69452-172-72	EA - Each	69452-172	f0fff21a-e0f5-4800-8ec4-e9fd6ef9d59a	1	2019-11-12
69452-172-74	EA - Each	69452-172	6922a1b1-13af-45a1-bf11-3636318606f7	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-172	AZITHROMYCIN TABLET, FILM COATED [BIONPHARMA INC.]	6	Current NDC, Legacy NDC, 5 package rows	20241212_859bb02c-a4bc-46fa-9fc9-def1219b5dfb.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	Bryant Ranch Prepack	b5d79719-b1dc-469f-a19c-f8ba615138f0	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210001 application number: ANDA210001
Azithromycin	AZITHROMYCIN	AvKARE	dc633b7d-5154-7e43-e053-2a95a90ad2a6	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210001 application number: ANDA210001
AZITHROMYCIN	AZITHROMYCIN	DIRECT RX	a5b4092d-ab72-f5d1-e053-2995a90ac582	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210001 application number: ANDA210001
Azithromycin	AZITHROMYCIN	Bionpharma Inc.	859bb02c-a4bc-46fa-9fc9-def1219b5dfb	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210001 application number: ANDA210001 ndc (product): 69452-172
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	b43d23c7-1a2e-ce93-e053-2995a90a65a4	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210001 application number: ANDA210001
Azithromycin	AZITHROMYCIN	Proficient Rx LP	34e6364a-ac3d-434e-a90c-cb13ebcf7983	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210001 application number: ANDA210001

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
248656	azithromycin 500 MG Oral Tablet	PSN	b5d79719-b1dc-469f-a19c-f8ba615138f0	103
248656	azithromycin 500 MG Oral Tablet	SCD	b5d79719-b1dc-469f-a19c-f8ba615138f0	103
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	b5d79719-b1dc-469f-a19c-f8ba615138f0	103
749780	{3 (azithromycin 500 MG Oral Tablet) } Pack	GPCK	859bb02c-a4bc-46fa-9fc9-def1219b5dfb	7
749780	{3 (azithromycin 500 MG Oral Tablet) } Pack	GPCK	a5b4092d-ab72-f5d1-e053-2995a90ac582	7
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	a5b4092d-ab72-f5d1-e053-2995a90ac582	7
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	859bb02c-a4bc-46fa-9fc9-def1219b5dfb	7
308460	azithromycin 250 MG Oral Tablet	PSN	859bb02c-a4bc-46fa-9fc9-def1219b5dfb	7
308460	azithromycin 250 MG Oral Tablet	PSN	a5b4092d-ab72-f5d1-e053-2995a90ac582	7
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	a5b4092d-ab72-f5d1-e053-2995a90ac582	7
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	859bb02c-a4bc-46fa-9fc9-def1219b5dfb	7
248656	azithromycin 500 MG Oral Tablet	PSN	a5b4092d-ab72-f5d1-e053-2995a90ac582	7
248656	azithromycin 500 MG Oral Tablet	PSN	859bb02c-a4bc-46fa-9fc9-def1219b5dfb	7
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	PSN	a5b4092d-ab72-f5d1-e053-2995a90ac582	7
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	PSN	859bb02c-a4bc-46fa-9fc9-def1219b5dfb	7
308460	azithromycin 250 MG Oral Tablet	SCD	859bb02c-a4bc-46fa-9fc9-def1219b5dfb	7
308460	azithromycin 250 MG Oral Tablet	SCD	a5b4092d-ab72-f5d1-e053-2995a90ac582	7
248656	azithromycin 500 MG Oral Tablet	SCD	a5b4092d-ab72-f5d1-e053-2995a90ac582	7
248656	azithromycin 500 MG Oral Tablet	SCD	859bb02c-a4bc-46fa-9fc9-def1219b5dfb	7
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	859bb02c-a4bc-46fa-9fc9-def1219b5dfb	7
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	a5b4092d-ab72-f5d1-e053-2995a90ac582	7
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	859bb02c-a4bc-46fa-9fc9-def1219b5dfb	7
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	a5b4092d-ab72-f5d1-e053-2995a90ac582	7
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	SY	859bb02c-a4bc-46fa-9fc9-def1219b5dfb	7
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	SY	a5b4092d-ab72-f5d1-e053-2995a90ac582	7
308460	azithromycin 250 MG Oral Tablet	PSN	dc633b7d-5154-7e43-e053-2a95a90ad2a6	4
248656	azithromycin 500 MG Oral Tablet	PSN	dc633b7d-5154-7e43-e053-2a95a90ad2a6	4
308460	azithromycin 250 MG Oral Tablet	SCD	dc633b7d-5154-7e43-e053-2a95a90ad2a6	4
248656	azithromycin 500 MG Oral Tablet	SCD	dc633b7d-5154-7e43-e053-2a95a90ad2a6	4
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	dc633b7d-5154-7e43-e053-2a95a90ad2a6	4
248656	azithromycin 500 MG Oral Tablet	PSN	b43d23c7-1a2e-ce93-e053-2995a90a65a4	3
248656	azithromycin 500 MG Oral Tablet	SCD	b43d23c7-1a2e-ce93-e053-2995a90a65a4	3
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	b43d23c7-1a2e-ce93-e053-2995a90a65a4	3
248656	azithromycin 500 MG Oral Tablet	PSN	34e6364a-ac3d-434e-a90c-cb13ebcf7983	2
248656	azithromycin 500 MG Oral Tablet	SCD	34e6364a-ac3d-434e-a90c-cb13ebcf7983	2
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	34e6364a-ac3d-434e-a90c-cb13ebcf7983	2
248656	azithromycin 500 MG Oral Tablet	PSN	1e1d6592-562f-56cc-e063-6394a90aa530	1
248656	azithromycin 500 MG Oral Tablet	SCD	1e1d6592-562f-56cc-e063-6394a90aa530	1
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	1e1d6592-562f-56cc-e063-6394a90aa530	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69452-172-13	69452017213	30 TABLET, FILM COATED in 1 BOTTLE (69452-172-13)		2019-03-12	0000-00-00	No	No	Current
69452-172-72	69452017272	3 BLISTER PACK in 1 CARTON (69452-172-72) / 3 TABLET, FILM COATED in 1 BLISTER PACK	3 blister pack	2019-10-10	0000-00-00	No	No	Current
69452-172-74	69452017274	1 BLISTER PACK in 1 CARTON (69452-172-74) / 3 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2019-10-10	0000-00-00	No	No	Current
69452-172-99	69452017299	6150 TABLET, FILM COATED in 1 DRUM (69452-172-99)		17-AUG-22				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azithromycin	Bryant Ranch Prepack	2026-05-14	HUMAN PRESCRIPTION DRUG LABEL	103
AZITHROMYCIN	DIRECT RX	2026-03-17	HUMAN PRESCRIPTION DRUG LABEL	7
Azithromycin	AvKARE	2026-03-17	HUMAN PRESCRIPTION DRUG LABEL	4
Azithromycin	REMEDYREPACK INC.	2025-12-19	HUMAN PRESCRIPTION DRUG LABEL	8
Azithromycin	Bionpharma Inc. \| Bluepharma Indústria Farmacêutica, S.A. \| OrBion Pharmaceuticals Private Limited	2025-12-04	HUMAN PRESCRIPTION DRUG LABEL	7
Azithromycin	RPK Pharmaceuticals, Inc.	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	3
Azithromycin	RedPharm Drug	2024-07-25	HUMAN PRESCRIPTION DRUG LABEL	1
Azithromycin	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	3
Azithromycin	Proficient Rx LP	2022-11-01	HUMAN PRESCRIPTION DRUG LABEL	2
Azithromycin	NuCare Pharmaceuticals,Inc.	2021-08-20	HUMAN PRESCRIPTION DRUG LABEL	1