Azithromycin Dihydrate

Product NDC: 72789-170
11-digit product format: 727890170
Labeler code: 72789
Product ID: 72789-170_e661766b-3a68-e830-e053-2995a90aa230
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin Dihydrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA208250
Marketing category: ANDA
Marketing start: 2019-07-01
Marketing end: 0000-00-00
Substance: AZITHROMYCIN DIHYDRATE
Active strength: 250 mg/1
Pharmacologic classes: Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	72789-170		D	Discontinued by firm		2026-08-03
excluded package	package	72789-170	72789-170-30	D	Discontinued by firm		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 · 2 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	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	72789-170		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72789-170	72789-170-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A208250-001	AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB		2019-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208250-001	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	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-04-17	`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	A208250-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208250-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208250-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208250-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208250-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208250-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208250-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208250-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208250-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208250-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208250-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208250-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208250-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208250-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208250-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208250-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208250-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208250-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208250-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208250-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208250-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208250-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208250-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208250-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208250-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208250-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208250-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208250-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208250-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208250-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208250-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208250-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208250-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208250-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208250-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208250-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208250-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208250-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208250-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208250-001	AB	1	`cb3db0bc1861…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-170-30	EA - Each	72789-170	fda8e954-5530-4e8a-8a85-838d3525aa4b	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-170	AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	10	Legacy NDC	20250328_334e208a-9093-476b-a781-6fa4e0c926dc.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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	PD-Rx Pharmaceuticals, Inc.	7ab854bf-eb04-42c4-a403-096b60581bb4	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Precision Dose, Inc.	d9b66736-3f1a-4d6d-bdc4-274f5adfb40c	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
AZITHROMYCIN	AZITHROMYCIN	DIRECT RX	a5b4092d-ab72-f5d1-e053-2995a90ac582	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	REMEDYREPACK INC.	f0cfda1a-910f-4764-8658-263037df5ea8	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Preferred Pharmaceuticals Inc.	b3c84aea-7ba7-4aae-999c-db740a9e53df	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	AvPAK	b635019e-7fd4-7f9e-e053-2a95a90a388c	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Redpharm Drug	44f52ce0-ad3f-7d80-e063-6294a90ad086	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	A-S Medication Solutions	df9b39b7-d42d-4c4b-b492-9fd228978dec	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	PD-Rx Pharmaceuticals, Inc.	e9800bbe-e8bf-4689-a8a5-dc23b5d2ee56	2025-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	TAGI Pharma, Inc.	9f0501bf-d1c4-46a5-b253-3b9e61015e82	2025-03-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Coupler LLC	2cc99fae-a72c-8893-e063-6394a90aa3ef	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Proficient Rx LP	a8e106cb-7245-45a5-9aad-bd624b1e011d	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Advanced Rx Pharmacy of Tennessee, LLC	f1752913-85ac-01fa-e053-2995a90a2bd8	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	NuCare Pharmaceuticals Inc.	258dd3c5-dce9-7483-e063-6294a90a4043	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Quality Care Products, LLC	2065c4ba-e3f5-41a2-b3d5-205dab646924	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	A-S Medication Solutions	1c84a68b-3eaa-4dab-b5e5-e195c7652e67	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Proficient Rx LP	8037c6f4-4881-4740-8229-2aee56141cd0	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Asclemed USA, Inc.	b08bd8fc-20da-4623-9211-ae669452b16d	2020-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5FD1131I7S	AZITHROMYCIN DIHYDRATE	117772-70-0	AZITHROMYCIN DIHYDRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-170-30	72789017030	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-170-30)	2021-03-12	0000-00-00	No	No	Current