Azithromycin Dihydrate

Product NDC: 50090-4527
11-digit product format: 500904527
Labeler code: 50090
Product ID: 50090-4527_73b54c1b-428f-40d2-b27e-79401310690e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin Dihydrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA208250
Marketing category: ANDA
Marketing start: 2019-07-01
Substance: AZITHROMYCIN DIHYDRATE
Active strength: 250 mg/1
Pharmacologic classes: Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308460	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
1c84a68b-3eaa-4dab-b5e5-e195c7652e67	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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	Strength	SPL version
50090-4527-0	Azithromycin Dihydrate	4 in 1 BOTTLE	TABLET, FILM COATED	4		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4527-0	EA - Each	50090-4527	11e108b4-8d10-4b16-ba7b-0699a32d612f	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4527	AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	10	Current NDC, Legacy NDC, 1 package rows	20240616_1c84a68b-3eaa-4dab-b5e5-e195c7652e67.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 ndc (product): 50090-4527
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308460	azithromycin 250 MG Oral Tablet	PSN	1c84a68b-3eaa-4dab-b5e5-e195c7652e67	10
308460	azithromycin 250 MG Oral Tablet	SCD	1c84a68b-3eaa-4dab-b5e5-e195c7652e67	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4527-0	50090452700	4 TABLET, FILM COATED in 1 BOTTLE (50090-4527-0)	2019-09-16	0000-00-00	No	No	Current