Application 076900

Type
ANDA
Sponsor
ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATENOLOLATENOLOLTABLET;ORAL25MGNoNo
002ATENOLOLATENOLOLTABLET;ORAL50MGNoNo
003ATENOLOLATENOLOLTABLET;ORAL100MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076900-001ATENOLOLATENOLOL25MGTABLET / ORALAB2005-01-28
A076900-002ATENOLOLATENOLOL50MGTABLET / ORALAB2005-01-28
A076900-003ATENOLOLATENOLOL100MGTABLET / ORALAB2005-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076900-001AB
A076900-002AB
A076900-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-288072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076900-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076900-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076900-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076900-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076900-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076900-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076900-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076900-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076900-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076900-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076900-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076900-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076900-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076900-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076900-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076900-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076900-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076900-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076900-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076900-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076900-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076900-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076900-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076900-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076900-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076900-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076900-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076900-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076900-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076900-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076900-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076900-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076900-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076900-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076900-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076900-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076900-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076900-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076900-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076900-001AB18072bd15b7f6…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLA-S Medication Solutionsb6fe1a12-a6d5-4c4c-9d77-6f717b43f8fe2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076900
application number: ANDA076900
AtenololATENOLOLA-S Medication Solutionsd21f2b4d-6584-48e5-8045-e5927ba033292026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076900
application number: ANDA076900
ndc (product): 50090-0442
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.8acdb229-928b-4c22-88f1-f4dd97cde2742025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076900
application number: ANDA076900
ndc (product): 43063-952
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.bdbf6779-8e9b-4ce1-a361-ede4914dd2f32025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076900
application number: ANDA076900
AtenololATENOLOLAmerican Health Packagingd19e9fcf-dfa1-43d7-94dc-e3f03fb90f5c2024-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076900
application number: ANDA076900
ndc (product): 60687-605
AtenololATENOLOLZydus Lifesciences Limited2492d5f6-00b0-42c9-a793-2be83ea81ad12024-11-25Exact identifier
application applno (ANDA): 076900
application number: ANDA076900
ndc (product): 65841-022
ndc (product): 65841-024
ndc (product): 65841-023
AtenololATENOLOLNuCare Pharmaceuticals, Inc.3d70576a-6fa7-481d-e054-00144ff88e882024-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076900
application number: ANDA076900
ndc (product): 66267-029
AtenololATENOLOLBryant Ranch Prepack67d9ca94-2af6-4ebb-a5c3-8d360f7412772024-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076900
application number: ANDA076900
AtenololATENOLOLZydus Pharmaceuticals USA Inc.db801706-1362-44c7-92ab-f584f96c7e1c2024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076900
application number: ANDA076900
ndc (product): 68382-023
ndc (product): 68382-022
ndc (product): 68382-024

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 104 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-031AtenololAtenololBlenheim Pharmacal, Inc.ANDACurrent
10544-126AtenololAtenololBlenheim Pharmacal, Inc.ANDACurrent
12634-605AtenololAtenololApotheca Inc.ANDACurrent
43063-952AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-952AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-952AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-952AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-952AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-952AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0442AtenololAtenololA-S Medication SolutionsANDACurrent
50090-0442AtenololAtenololA-S Medication SolutionsANDACurrent
50090-0448AtenololAtenololA-S Medication SolutionsANDACurrent
50090-0514AtenololAtenololA-S Medication SolutionsANDACurrent
53217-181AtenololAtenololAidarex Pharmaceuticals LLCANDACurrent
53217-365AtenololAtenololAidarex Pharmaceuticals LLCANDACurrent
53808-0207AtenololAtenololState of Florida DOH Central PharmacyANDACurrent
53808-0344AtenololAtenololState of Florida DOH Central PharmacyANDACurrent
53808-0730AtenololAtenololState of Florida DOH Central PharmacyANDACurrent
55700-531AtenololAtenololLake Erie Medical DBA Quality Care Procucts LLCANDACurrent
55700-531AtenololAtenololLake Erie Medical DBA QuaANDACurrent
55700-531AtenololAtenololLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-531AtenololAtenololLake Erie Medical DBA Quality Care Procucts LLCANDACurrent
55700-566AtenololAtenololLake Erie Medical DBA Quality Care Procucts LLCANDACurrent
55700-566AtenololAtenololLake Erie Medical DBA QuaANDACurrent
55700-566AtenololAtenololLake Erie Medical DBA Quality Care Procucts LLCANDACurrent
55700-567AtenololAtenololLake Erie Medical DBA Quality Care Procucts LLCANDACurrent
55700-567AtenololAtenololLake Erie Medical DBA QuaANDACurrent
58118-2022AtenololAtenololClinical Solutions WholesANDACurrent
60687-605AtenololAtenololAmerican Health PackagingANDACurrent
60687-605AtenololAtenololAmerican Health PackagingANDACurrent
60760-163AtenololAtenololSt. Mary's Medical Park PharmacyANDACurrent
60760-164AtenololAtenololSt. Mary's Medical Park PharmacyANDACurrent
61919-581ATENOLOLATENOLOLDIRECT RXANDACurrent
61919-581ATENOLOLATENOLOLDIRECT RXANDACurrent
61919-935ATENOLOLATENOLOLDIRECT RXANDACurrent
61919-935ATENOLOLATENOLOLDirect_RxANDACurrent
61919-935ATENOLOLATENOLOLDirect_RxANDACurrent
65841-022AtenololAtenololCadila Healthcare LimitedANDACurrent
65841-022AtenololAtenololCadila Healthcare LimitedANDACurrent
65841-022AtenololAtenololZydus Lifesciences LimitedANDACurrent
65841-022AtenololAtenololCadila Healthcare LimitedANDACurrent
65841-023AtenololAtenololCadila Healthcare LimitedANDACurrent
65841-023AtenololAtenololCadila Healthcare LimitedANDACurrent
65841-023AtenololAtenololZydus Lifesciences LimitedANDACurrent
65841-023AtenololAtenololCadila Healthcare LimitedANDACurrent
65841-024AtenololAtenololCadila Healthcare LimitedANDACurrent
65841-024AtenololAtenololCadila Healthcare LimitedANDACurrent
65841-024AtenololAtenololZydus Lifesciences LimitedANDACurrent
65841-024AtenololAtenololCadila Healthcare LimitedANDACurrent
66267-029AtenololAtenololNuCare Pharmaceuticals, Inc.ANDACurrent
66267-029AtenololAtenololNuCare Pharmaceuticals, Inc.ANDACurrent
66267-031AtenololAtenololNuCare Pharmaceuticals, Inc.ANDACurrent
66267-031AtenololAtenololNuCare Pharmaceuticals, Inc.ANDACurrent
67296-1558AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1558AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1558AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1589AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1589AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1589AtenololAtenololRedPharm Drug, Inc.ANDACurrent
68071-2248AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2248AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3190AtenololAtenololNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3190AtenololAtenololNuCare Pharmaceuticals, Inc.ANDACurrent
68151-2471AtenololAtenololCarilion Materials ManagementANDACurrent
68151-2889AtenololAtenololCarilion Materials ManagementANDACurrent
68382-022AtenololAtenololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-022AtenololAtenololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-022AtenololAtenololZydus Pharmaceuticals USA Inc.ANDACurrent
68382-023AtenololAtenololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-023AtenololAtenololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-023AtenololAtenololZydus Pharmaceuticals USA Inc.ANDACurrent
68382-024AtenololAtenololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-024AtenololAtenololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-024AtenololAtenololZydus Pharmaceuticals USA Inc.ANDACurrent
68645-493AtenololAtenololLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-493AtenololAtenololLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-493AtenololAtenololLegacy Pharmaceutical Packaging, LLCANDACurrent
68788-6458AtenololAtenololPreferred Pharmaceuticals Inc.ANDACurrent
68788-6458AtenololAtenololPreferred Pharmaceuticals Inc.ANDACurrent
68788-6969AtenololAtenololPreferred Pharmaceuticals Inc.ANDACurrent