Application 065153

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZITHROMYCIN	AZITHROMYCIN	TABLET;ORAL	EQ 250MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A065153-001	AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL			2005-11-14

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 · 43 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
2026-09-14 22:38:34	2026-08	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065153-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL		2005-11-14	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A065153-001	AB	1	`ea99ee380514…`

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 4 of 6 · 109 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AZITHROMYCIN	AZITHROMYCIN	Direct_Rx	8e6e11fb-eb9e-28ec-e053-2a95a90aa1a3	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: AZITHROMYCIN generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	DirectRx	d564d91e-3039-c120-e053-2995a90ae6db	2025-01-21	Warnings, Adverse reactions	Name fallback brand name: AZITHROMYCIN generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Zydus Lifesciences Limited	0b63649d-558c-4250-90ee-af6e1e5c6d2c	2025-01-09		Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Advanced Rx Pharmacy of Tennessee, LLC	f175496a-4ad3-ce0d-e053-2a95a90a6613	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN MONOHYDRATE	Fresenius Kabi USA, LLC	b69917c0-95d5-4b29-b0e3-07054a4fd79f	2024-10-11	Warnings, Adverse reactions	Name fallback brand name: Azithromycin
Azithromycin	AZITHROMYCIN MONOHYDRATE	Fresenius Kabi USA, LLC	9ad099d5-5c57-4855-98a4-e03fb4629dbf	2024-10-11	Warnings, Adverse reactions	Name fallback brand name: Azithromycin
Azithromycin	AZITHROMYCIN	Asclemed USA, Inc.	22a4d2b3-daea-4d96-891f-4b9823629456	2024-10-04	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Proficient Rx LP	90605f94-93e1-43d1-8be7-830e816ac84f	2024-10-01	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Proficient Rx LP	38942011-f86b-4e42-a4ca-05a70d9dd3d9	2024-10-01	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN MONOHYDRATE	Sagent Pharmaceuticals	6497fb5e-82d8-4411-b994-7ee01333ffd7	2024-09-19	Warnings, Adverse reactions	Name fallback brand name: Azithromycin
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	f97d2e7e-ccfd-4f04-85ba-549b37f6aa7b	2024-07-22	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	b0138503-ddc4-2e1c-e053-2995a90a0d2d	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	b43d23c7-1a2e-ce93-e053-2995a90a65a4	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	549cdd0a-da79-23b8-e054-00144ff8d46c	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	90a506cd-aae7-a622-e053-2a95a90ad352	2024-06-19	Warnings, Adverse reactions	Name fallback brand name: AZITHROMYCIN generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	9270e676-3382-6483-e053-2a95a90a556e	2024-06-19	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	8e7184e1-3c3c-cd87-e053-2a95a90a6eb6	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	82454fb2-e524-ecb8-e053-2991aa0a6e7c	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: AZITHROMYCIN generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	826f9c07-8eb9-a128-e053-2991aa0ad654	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	8389c336-25eb-a96f-e053-2a91aa0a0dd8	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: AZITHROMYCIN generic name: AZITHROMYCIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7146	Azithromycin	Azithromycin	Teva Pharmaceuticals USA,	ANDA	Current
50090-1646	Azithromycin	Azithromycin	A-S Medication Solutions	ANDA	Current
50436-4357	Azithromycin	Azithromycin	Unit Dose Services	ANDA	Current
55695-028	Azithromycin	Azithromycin	Department of State Health Services, Pharmacy Branch	ANDA	Current
66116-418	Azithromycin	Azithromycin	MedVantx, Inc.	ANDA	Current
66116-509	Azithromycin	Azithromycin	MedVantx, Inc.	ANDA	Current
67296-0192	Azithromycin	Azithromycin	RedPharm Drug, Inc.	ANDA	Current
67296-0192	Azithromycin	Azithromycin	RedPharm Drug, Inc.	ANDA	Current
68071-1392	Azithromycin	Azithromycin	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-1873	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3006	Azithromycin	Azithromycin	NuCare Pharmaceuticals, Inc..	ANDA	Current
70518-0353	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
76413-152	Azithromycin	Azithromycin	Central Texas Community Health Centers	ANDA	Current