AZITHROMYCIN MONOHYDRATE

Product NDC: 61919-170
Requested package NDC: 61919-170-06
11-digit product format: 619190170
Labeler code: 61919
Product ID: 61919-170_92c05d6e-133b-b404-e053-2995a90a4ba8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AZITHROMYCIN MONOHYDRATE
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA065398
Marketing category: ANDA
Marketing start: 2019-09-17
Marketing end: 0000-00-00
Substance: AZITHROMYCIN MONOHYDRATE
Active strength: 250 mg/1
Pharmacologic classes: Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61919-170	61919-170-06	I	Inactivated by FDA		2026-08-03

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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
A065398-001	AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB		2015-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065398-001	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	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`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	A065398-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065398-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065398-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065398-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065398-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065398-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065398-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065398-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065398-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065398-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065398-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065398-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065398-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065398-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065398-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065398-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065398-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065398-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065398-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065398-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065398-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065398-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065398-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065398-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065398-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065398-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065398-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065398-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065398-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065398-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065398-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065398-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065398-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065398-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065398-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065398-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065398-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065398-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065398-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065398-001	AB	1	`cb3db0bc1861…`

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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-170-06	2023-01-30	C162847	48780-1	f386c64a-3586-0266-e053-dadaa90a7c1a	AZITHROMYCIN MONOHYDRATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-170-06	AZITHROMYCIN MONOHYDRATE	6 in 1 BLISTER PACK	TABLET	6		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-170-06	EA - Each	61919-170	04eddd3d-6a4a-4d8d-acb3-7deef34e614f	1	2019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-170	AZITHROMYCIN MONOHYDRATE TABLET [DIRECT_RX]	1	Legacy NDC, 1 package rows	20190917_92c05d6e-133a-b404-e053-2995a90a4ba8.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	Coupler LLC	510024c9-6658-e08f-e063-6294a90a0793	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065398 application number: ANDA065398
azithromycin	AZITHROMYCIN	Cardinal Health 107, LLC	ea128124-8712-4998-be46-47d43ef127d4	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065398 application number: ANDA065398
azithromycin	AZITHROMYCIN	Lupin Pharmaceuticals, Inc.	01649d79-4677-4577-a3e4-e054f3f9fc3b	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065398 application number: ANDA065398
azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	da399401-1ee6-422a-be46-0bba6b264b2f	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065398 application number: ANDA065398
azithromycin	AZITHROMYCIN	Major Pharmaceuticals	814abe38-da4a-48af-bf4b-2ce04a5aabd1	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065398 application number: ANDA065398
Azithromycin	AZITHROMYCIN	American Health Packaging	6169e56c-10fb-448d-ab0f-14e54fcf2817	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065398 application number: ANDA065398
azithromycin	AZITHROMYCIN	Proficient Rx LP	25bc2e78-9d0d-41c6-a55e-a267d4457967	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065398 application number: ANDA065398
azithromycin dihydrate	AZITHROMYCIN DIHYDRATE	Advanced Rx of Tennessee, LLC	20ae108a-00c5-a984-e063-6394a90aaaae	2024-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065398 application number: ANDA065398

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
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	92c05d6e-133a-b404-e053-2995a90a4ba8	1
308460	azithromycin 250 MG Oral Tablet	PSN	92c05d6e-133a-b404-e053-2995a90a4ba8	1
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	92c05d6e-133a-b404-e053-2995a90a4ba8	1
308460	azithromycin 250 MG Oral Tablet	SCD	92c05d6e-133a-b404-e053-2995a90a4ba8	1
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	92c05d6e-133a-b404-e053-2995a90a4ba8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-170-06	61919017006	6 TABLET in 1 BLISTER PACK (61919-170-06)	6 tablet	2019-09-17	0000-00-00	No	No	Current