Application 076900

Type: ANDA
Sponsor: ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATENOLOL	ATENOLOL	TABLET;ORAL	25MG	No	No
002	ATENOLOL	ATENOLOL	TABLET;ORAL	50MG	No	No
003	ATENOLOL	ATENOLOL	TABLET;ORAL	100MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076900-001	ATENOLOL	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28
A076900-002	ATENOLOL	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28
A076900-003	ATENOLOL	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A076900-001	AB
A076900-002	AB
A076900-003	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 4 · 129 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	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076900-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076900-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076900-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076900-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076900-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076900-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076900-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076900-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076900-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076900-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076900-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076900-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076900-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076900-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076900-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076900-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076900-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076900-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076900-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076900-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076900-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076900-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076900-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076900-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076900-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076900-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076900-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076900-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076900-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076900-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076900-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076900-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076900-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076900-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076900-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076900-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076900-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076900-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076900-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076900-001	AB	1	`301d65b070ca…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	A-S Medication Solutions	b6fe1a12-a6d5-4c4c-9d77-6f717b43f8fe	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	A-S Medication Solutions	d21f2b4d-6584-48e5-8045-e5927ba03329	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	PD-Rx Pharmaceuticals, Inc.	8acdb229-928b-4c22-88f1-f4dd97cde274	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	PD-Rx Pharmaceuticals, Inc.	bdbf6779-8e9b-4ce1-a361-ede4914dd2f3	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900 ndc (product): 72789-144
Atenolol	ATENOLOL	American Health Packaging	d19e9fcf-dfa1-43d7-94dc-e3f03fb90f5c	2024-12-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	Zydus Lifesciences Limited	2492d5f6-00b0-42c9-a793-2be83ea81ad1	2024-11-25		Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	NuCare Pharmaceuticals, Inc.	3d70576a-6fa7-481d-e054-00144ff88e88	2024-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	Bryant Ranch Prepack	67d9ca94-2af6-4ebb-a5c3-8d360f741277	2024-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900 ndc (product): 71335-0540 ndc (product): 71335-0912
Atenolol	ATENOLOL	Zydus Pharmaceuticals USA Inc.	db801706-1362-44c7-92ab-f584f96c7e1c	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900

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 2 of 2 · 104 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68788-6969	Atenolol	Atenolol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6969	Atenolol	Atenolol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7071	Atenolol	Atenolol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7071	Atenolol	Atenolol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7071	Atenolol	Atenolol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7071	Atenolol	Atenolol	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0025	Atenolol	Atenolol	REMEDYREPACK INC.	ANDA	Current
70518-0188	Atenolol	Atenolol	REMEDYREPACK INC.	ANDA	Current
70518-0188	Atenolol	Atenolol	REMEDYREPACK INC.	ANDA	Current
70518-0188	Atenolol	Atenolol	REMEDYREPACK INC.	ANDA	Current
70518-0984	Atenolol	Atenolol	REMEDYREPACK INC.	ANDA	Current
70518-0984	Atenolol	Atenolol	REMEDYREPACK INC.	ANDA	Current
70518-0984	Atenolol	Atenolol	REMEDYREPACK INC.	ANDA	Current
70518-1238	Atenolol	Atenolol	REMEDYREPACK INC.	ANDA	Current
70934-142	Atenolol	Atenolol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-142	Atenolol	Atenolol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-142	Atenolol	Atenolol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0540	Atenolol	Atenolol	Bryant Ranch Prepack	ANDA	Current
71335-0912	Atenolol	Atenolol	Bryant Ranch Prepack	ANDA	Current
71335-0912	Atenolol	Atenolol	Bryant Ranch Prepack	ANDA	Current
72789-144	Atenolol	Atenolol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-144	Atenolol	Atenolol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-144	Atenolol	Atenolol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-144	Atenolol	Atenolol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current