Azithromycin

Product NDC: 65862-641
11-digit product format: 658620641
Labeler code: 65862
Product ID: 65862-641_db155bb5-7adc-494a-be66-a2e8e4a45fe1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA207370
Marketing category: ANDA
Marketing start: 2018-07-05
Substance: AZITHROMYCIN DIHYDRATE
Active strength: 250 mg/1
Pharmacologic classes: Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
unfinished product	product	65862-641		UNFINISHED	Active or certified unfinished drug listing	2026-08-10
unfinished package	package	65862-641	65862-641-25	UNFINISHED	Active or certified unfinished drug listing	2026-08-10
unfinished package	package	65862-641	65862-641-55	UNFINISHED	Active or certified unfinished drug listing	2026-08-10

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 · 54 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	65862-641-25	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-641-55	`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	65862-641-25	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-641-55	`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	65862-641-25	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-641-55	`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	65862-641-25	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-641-55	`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	65862-641-25	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-641-55	`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	65862-641-25	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-641-55	`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	65862-641-25	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-641-55	`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	65862-641-25	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-641-55	`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	65862-641-25	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-641-55	`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	65862-641-25	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-641-55	`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	65862-641-25	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-641-55	`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	65862-641-25	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-641-55	`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	65862-641-25	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-641-55	`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	65862-641-25	`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-641-55	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-641-25	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-641-55	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-641-25	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-641-55	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-641-25	`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-641-55	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-641-55	`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-641-25	`4184dd79f89f…`	`545327b3e20f…`

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
A207370-001	AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB		2018-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207370-001	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	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`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	A207370-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207370-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207370-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207370-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207370-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207370-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207370-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207370-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207370-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207370-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207370-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207370-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207370-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207370-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207370-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207370-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207370-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207370-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207370-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207370-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207370-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207370-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207370-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207370-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207370-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207370-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207370-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207370-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207370-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207370-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207370-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207370-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207370-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207370-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207370-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207370-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207370-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207370-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207370-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207370-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Azithromycin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZITHROMYCIN DIHYDRATE	250 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
795c13cd-e9ca-481b-9fa9-2890bdf9dac8	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
65862-641-01	Azithromycin	100 in 1 BOTTLE	TABLET, FILM COATED	100	8
65862-641-05	Azithromycin	500 in 1 BOTTLE	TABLET, FILM COATED	500	8
65862-641-30	Azithromycin	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
65862-641-50	Azithromycin	50 in 1 BOTTLE	TABLET, FILM COATED	50	8
65862-641-63	Azithromycin	3 in 1 CARTON	TABLET, FILM COATED	3	8
65862-641-63	Azithromycin	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	8
65862-641-69	Azithromycin	1 in 1 CARTON	TABLET, FILM COATED	1	8
65862-641-69	Azithromycin	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-641-30	EA - Each	65862-641	2f2fa59c-8fff-4d95-9dfc-03819d190524	1	2018-09-05
65862-641-63	EA - Each	65862-641	b934ce1d-4b36-4381-88b9-3a7c64c543a4	1	2018-09-05
65862-641-69	EA - Each	65862-641	408c6b72-2002-48d3-84ce-8b65e6c13cae	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-641	AZITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7	Current NDC, Legacy NDC, 8 package rows	20240806_795c13cd-e9ca-481b-9fa9-2890bdf9dac8.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	a9cdb5ae-2aeb-c598-e053-2a95a90a8062	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370
Azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	5f144e92-c9eb-420a-9bb8-4265a9f20a98	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	3b7e16b1-9a3c-4e3a-8411-841a708afe45	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	6caeda98-7020-413a-9461-04f476dad4ba	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	3c4861f2-825e-4e3b-9907-9658a849079e	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370
Azithromycin	AZITHROMYCIN	Aurobindo Pharma Limited	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370 ndc (product): 65862-641
AZITHROMYCIN	AZITHROMYCIN	DIRECT RX	a5b4092d-ab72-f5d1-e053-2995a90ac582	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	4eec460d-5ba8-4614-8700-219a9b4fc385	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	47a8fd64-5a3d-490e-8ca8-5e6721c830cf	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	896cce83-23ac-f4ed-e053-2a95a90ad107	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	4278e306-bc26-4282-93ce-f1405e0b5d4a	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370
Azithromycin	AZITHROMYCIN	Proficient Rx LP	cb40f4cf-15ae-47ab-8e0a-979467fa0d9e	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370

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
308460	azithromycin 250 MG Oral Tablet	PSN	5f144e92-c9eb-420a-9bb8-4265a9f20a98	17
308460	azithromycin 250 MG Oral Tablet	SCD	5f144e92-c9eb-420a-9bb8-4265a9f20a98	17
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	4278e306-bc26-4282-93ce-f1405e0b5d4a	9
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	47a8fd64-5a3d-490e-8ca8-5e6721c830cf	9
308460	azithromycin 250 MG Oral Tablet	PSN	4278e306-bc26-4282-93ce-f1405e0b5d4a	9
308460	azithromycin 250 MG Oral Tablet	PSN	47a8fd64-5a3d-490e-8ca8-5e6721c830cf	9
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	4278e306-bc26-4282-93ce-f1405e0b5d4a	9
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	47a8fd64-5a3d-490e-8ca8-5e6721c830cf	9
308460	azithromycin 250 MG Oral Tablet	SCD	4278e306-bc26-4282-93ce-f1405e0b5d4a	9
308460	azithromycin 250 MG Oral Tablet	SCD	47a8fd64-5a3d-490e-8ca8-5e6721c830cf	9
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	47a8fd64-5a3d-490e-8ca8-5e6721c830cf	9
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	4278e306-bc26-4282-93ce-f1405e0b5d4a	9
749780	{3 (azithromycin 500 MG Oral Tablet) } Pack	GPCK	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	8
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	8
308460	azithromycin 250 MG Oral Tablet	PSN	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	8
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	8
248656	azithromycin 500 MG Oral Tablet	PSN	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	8
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	PSN	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	8
308460	azithromycin 250 MG Oral Tablet	SCD	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	8
248656	azithromycin 500 MG Oral Tablet	SCD	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	8
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	8
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	8
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	SY	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	8
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
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
248656	azithromycin 500 MG Oral Tablet	PSN	a5b4092d-ab72-f5d1-e053-2995a90ac582	7
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	PSN	a5b4092d-ab72-f5d1-e053-2995a90ac582	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
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	a5b4092d-ab72-f5d1-e053-2995a90ac582	7
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	SY	a5b4092d-ab72-f5d1-e053-2995a90ac582	7
308460	azithromycin 250 MG Oral Tablet	PSN	a9cdb5ae-2aeb-c598-e053-2a95a90a8062	6
308460	azithromycin 250 MG Oral Tablet	SCD	a9cdb5ae-2aeb-c598-e053-2a95a90a8062	6
308460	azithromycin 250 MG Oral Tablet	PSN	cb40f4cf-15ae-47ab-8e0a-979467fa0d9e	5
308460	azithromycin 250 MG Oral Tablet	SCD	cb40f4cf-15ae-47ab-8e0a-979467fa0d9e	5
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	4eec460d-5ba8-4614-8700-219a9b4fc385	4
308460	azithromycin 250 MG Oral Tablet	PSN	4eec460d-5ba8-4614-8700-219a9b4fc385	4
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	4eec460d-5ba8-4614-8700-219a9b4fc385	4
308460	azithromycin 250 MG Oral Tablet	SCD	4eec460d-5ba8-4614-8700-219a9b4fc385	4
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	4eec460d-5ba8-4614-8700-219a9b4fc385	4
308460	azithromycin 250 MG Oral Tablet	PSN	896cce83-23ac-f4ed-e053-2a95a90ad107	3
308460	azithromycin 250 MG Oral Tablet	SCD	896cce83-23ac-f4ed-e053-2a95a90ad107	3
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	5a8f7836-17ef-4944-a86f-dc162a5c8e55	1
308460	azithromycin 250 MG Oral Tablet	PSN	dc8e486e-619f-4ee1-e053-2a95a90a7940	1
308460	azithromycin 250 MG Oral Tablet	PSN	3c4861f2-825e-4e3b-9907-9658a849079e	1
308460	azithromycin 250 MG Oral Tablet	PSN	f05c3199-e5cd-3a89-e053-2995a90acf5f	1
308460	azithromycin 250 MG Oral Tablet	PSN	5a8f7836-17ef-4944-a86f-dc162a5c8e55	1
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	5a8f7836-17ef-4944-a86f-dc162a5c8e55	1
308460	azithromycin 250 MG Oral Tablet	SCD	5a8f7836-17ef-4944-a86f-dc162a5c8e55	1
308460	azithromycin 250 MG Oral Tablet	SCD	dc8e486e-619f-4ee1-e053-2a95a90a7940	1
308460	azithromycin 250 MG Oral Tablet	SCD	f05c3199-e5cd-3a89-e053-2995a90acf5f	1
308460	azithromycin 250 MG Oral Tablet	SCD	3c4861f2-825e-4e3b-9907-9658a849079e	1
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	5a8f7836-17ef-4944-a86f-dc162a5c8e55	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-641-01	65862064101	100 TABLET, FILM COATED in 1 BOTTLE (65862-641-01)		2018-07-05	0000-00-00	No	No	Current
65862-641-05	65862064105	500 TABLET, FILM COATED in 1 BOTTLE (65862-641-05)		2018-07-05	0000-00-00	No	No	Current
65862-641-25	65862064125	25000 TABLET, FILM COATED in 1 BAG (65862-641-25)		16-SEP-20				Current
65862-641-30	65862064130	30 TABLET, FILM COATED in 1 BOTTLE (65862-641-30)		2018-07-05	0000-00-00	No	No	Current
65862-641-50	65862064150	50 TABLET, FILM COATED in 1 BOTTLE (65862-641-50)		2018-07-05	0000-00-00	No	No	Current
65862-641-55	65862064155	15000 TABLET, FILM COATED in 1 BAG (65862-641-55)		16-SEP-20				Current
65862-641-63	65862064163	3 BLISTER PACK in 1 CARTON (65862-641-63) / 6 TABLET, FILM COATED in 1 BLISTER PACK	3 blister pack	2018-07-05	0000-00-00	No	No	Current
65862-641-69	65862064169	1 BLISTER PACK in 1 CARTON (65862-641-69) / 6 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2018-07-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azithromycin	NuCare Pharmaceuticals,Inc.	2026-07-30	HUMAN PRESCRIPTION DRUG LABEL	7
Azithromycin	REMEDYREPACK INC.	2026-07-24	HUMAN PRESCRIPTION DRUG LABEL	18
Azithromycin	A-S Medication Solutions	2026-07-23	Human Prescription Drug Label	1
Azithromycin	Bryant Ranch Prepack	2026-07-20	HUMAN PRESCRIPTION DRUG LABEL	101
Azithromycin	A-S Medication Solutions	2026-07-16	Human Prescription Drug Label	4
Azithromycin	Aurobindo Pharma Limited	2026-04-16	Human Prescription Drug Label	8
AZITHROMYCIN	DIRECT RX	2026-03-17	HUMAN PRESCRIPTION DRUG LABEL	7
Azithromycin	Preferred Pharmaceuticals Inc.	2026-03-16	HUMAN PRESCRIPTION DRUG LABEL	4
Azithromycin	A-S Medication Solutions	2025-05-01	Human Prescription Drug Label	9
Azithromycin	St. Mary's Medical Park Pharmacy	2024-12-13	HUMAN PRESCRIPTION DRUG LABEL	2
Azithromycin	NuCare Pharmaceuticals,Inc.	2024-06-14	HUMAN PRESCRIPTION DRUG LABEL	3
Azithromycin	A-S Medication Solutions	2024-06-12	Human Prescription Drug Label	9
Azithromycin	Preferred Pharmaceuticals, Inc.	2024-01-15	HUMAN PRESCRIPTION DRUG LABEL	5
Azithromycin	NuCare Pharmaceuticals,Inc.	2022-12-21	HUMAN PRESCRIPTION DRUG LABEL	1
Azithromycin	Quality Care Products, LLC	2022-08-17	Human Prescription Drug Label	2
Azithromycin	Proficient Rx LP	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	5
Azithromycin	NuCare Pharmaceuticals,Inc.	2022-04-13	HUMAN PRESCRIPTION DRUG LABEL	1
Azithromycin	RPK Pharmaceuticals, Inc.	2022-03-30	Human Prescription Drug Label	1
Azithromycin	Bryant Ranch Prepack	2022-02-03	HUMAN PRESCRIPTION DRUG LABEL	3