Azithromycin

Product NDC: 68071-5058
Requested package NDC: 68071-5058-3
11-digit product format: 680715058
Labeler code: 68071
Product ID: 68071-5058_1b4318a7-a74c-c7bc-e063-6394a90aeafb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA207398
Marketing category: ANDA
Marketing start: 2018-07-05
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

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-5058	68071-5058-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-5058	68071-5058-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-5058	68071-5058-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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
A207398-001	AZITHROMYCIN	AZITHROMYCIN	EQ 500MG 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
A207398-001	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	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207398-001	AZITHROMYCIN	EQ 500MG 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	A207398-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207398-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207398-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207398-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207398-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207398-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207398-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207398-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207398-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207398-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207398-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207398-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207398-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207398-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207398-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207398-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207398-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207398-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207398-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207398-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207398-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207398-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207398-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207398-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207398-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207398-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207398-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207398-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207398-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207398-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207398-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207398-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207398-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207398-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207398-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207398-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207398-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207398-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207398-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207398-001	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
248656	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
9270e676-3382-6483-e053-2a95a90a556e	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-06-19	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
2023-01-30	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
2021-02-19	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
2021-01-29	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-5058-3	Azithromycin	3 in 1 BLISTER PACK	TABLET, FILM COATED	3		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-5058	AZITHROMYCIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240620_9270e676-3382-6483-e053-2a95a90a556e.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	882f71b1-b153-4856-b4a7-1a29ae9cf247	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	58308e8b-57bd-4e82-a2e8-24aac63194cd	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	2a8010dc-700f-45d3-94ca-ebe4a51acc1b	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	Aurobindo Pharma Limited	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	a81212ef-76b6-4bd7-8706-3d2b05ee34f9	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	24c07398-84ad-48e2-9625-e9073c28fb73	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	77c5e4c6-6d16-40fe-bf36-cb441348f39b	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	003307c5-3f73-4a5d-a704-bfdea3c656e8	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	Redpharm Drug	2fd25741-f014-3999-e063-6394a90acdd0	2025-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	94e17ae5-0871-67a0-e053-2995a90ae0ae	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
AZITHROMYCIN	AZITHROMYCIN	Direct_Rx	8e6e11fb-eb9e-28ec-e053-2a95a90aa1a3	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	9270e676-3382-6483-e053-2a95a90a556e	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398 ndc (package): 68071-5058-3 ndc (product): 68071-5058 ndc11 (package): 68071505803
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	8e7184e1-3c3c-cd87-e053-2a95a90a6eb6	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	Proficient Rx LP	25f2d819-ae38-4061-a897-bbcfce3739bf	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398

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	9270e676-3382-6483-e053-2a95a90a556e	3
248656	azithromycin 500 MG Oral Tablet	SCD	9270e676-3382-6483-e053-2a95a90a556e	3
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	9270e676-3382-6483-e053-2a95a90a556e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-5058-3	68071505803	3 TABLET, FILM COATED in 1 BLISTER PACK (68071-5058-3)	2019-09-13	0000-00-00	No	No	Current