FDA.reportPublic FDA data

Application 074056

Type
ANDA
Sponsor
TEVA

Application Products#

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

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
A074056-001ATENOLOLATENOLOL50MGTABLET / ORALAB1995-01-18
A074056-002ATENOLOLATENOLOL100MGTABLET / ORALAB1995-01-18
A074056-003ATENOLOLATENOLOL25MGTABLET / ORALAB2004-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074056-001AB
A074056-002AB
A074056-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18a50c72e98297…
2026-08-01 22:54:322026-06A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18a50c72e98297…
2026-08-01 22:54:322026-06A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A074056-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A074056-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A074056-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLQPharma, Inc.70d7a585-7a46-4eac-b2b5-2ac5b98d98822025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
ndc (product): 42708-012
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.95761173-1c95-46b2-a08f-fbc3e70daba82025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
ndc (product): 43063-805
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.c69b8e5e-c7c3-4883-9cea-f7f435a8ede82025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
ndc (product): 43063-765
AtenololATENOLOLAphena Pharma Solutions - Tennessee, LLC23e96396-85d3-0d8e-e063-6394a90a614d2024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLAphena Pharma Solutions - Tennessee, LLC247569d6-9a73-f1d0-e063-6394a90a667a2024-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLNuCare Pharmaceuticals,Inc.7366c6f8-4cb3-520e-e053-2991aa0a2cc82024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLTeva Pharmaceuticals USA, Inc.25a72ec9-de0f-44e5-90b8-da1aab0d35882024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
ndc (product): 0093-0752
ndc (product): 0093-0787
ndc (product): 0093-0753
AtenololATENOLOLA-S Medication Solutionsd73a475a-c8c9-44a0-89ac-6a2d665c0d242023-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLProficient Rx LP24f1f3f4-bbda-458b-b15f-d942c90534e22022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
ndc (product): 63187-537
AtenololATENOLOLBryant Ranch Prepackba0b0221-d4b3-4cb1-9435-53a75fcc4b402020-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLProficient Rx LPb198b34c-861a-4b52-b4df-8c48b807520a2020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
ndc (product): 63187-710

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 150 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0752AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0752AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0752AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0752AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0753AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0753AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0753AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0753AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0787AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0787AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0787AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0787AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-8026AtenololAtenololNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8026AtenololAtenololNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8027AtenololAtenololNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8027AtenololAtenololNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
12634-604AtenololAtenololApotheca Inc.ANDACurrent
42291-140AtenololAtenololAvKARE, Inc.ANDACurrent
42291-141AtenololAtenololAvKARE, Inc.ANDACurrent
42291-142AtenololAtenololAvKARE, Inc.ANDACurrent
42708-012AtenololAtenololQPharma IncANDACurrent
42708-012AtenololAtenololQPharma IncANDACurrent
42708-012AtenololAtenololQPharma IncANDACurrent
43063-765AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-765AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-765AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-765AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-765AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-765AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-805AtenololAtenololPD-Rx Pharmaceuticals, InANDACurrent
43063-805AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-805AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-805AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-805AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-805AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-805AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-833AtenololAtenololAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-3043AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3043AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3043AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3071AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3410AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3410AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3410AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3410AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3411AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3411AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3411AtenololAtenololA-S Medication SolutionsANDACurrent
50436-0752AtenololAtenololUnit Dose ServicesANDACurrent
50436-0753AtenololAtenololUnit Dose ServicesANDACurrent
53002-1004AtenololAtenololRPK Pharmaceuticals, Inc.ANDACurrent
53002-1004AtenololAtenololRPK Pharmaceuticals, Inc.ANDACurrent
53002-1108AtenololAtenololRPK Pharmaceuticals, Inc.ANDACurrent
53002-1108AtenololAtenololRPK Pharmaceuticals, Inc.ANDACurrent
53002-1138AtenololAtenololRPK Pharmaceuticals, Inc.ANDACurrent
53002-1138AtenololAtenololRPK Pharmaceuticals, Inc.ANDACurrent
53217-201AtenololAtenololAidarex Pharmaceuticals LLCANDACurrent
53217-237AtenololAtenololAidarex Pharmaceuticals LLCANDACurrent
60760-787AtenololAtenololSt Mary's Medical Park PharmacyANDACurrent
61919-279ATENOLOLATENOLOLDirectRXANDACurrent
61919-279ATENOLOLATENOLOLDIRECT RXANDACurrent
61919-279ATENOLOLATENOLOLDIRECT RXANDACurrent
61919-279ATENOLOLATENOLOLDirect_RxANDACurrent
61919-279ATENOLOLATENOLOLDirect_RxANDACurrent
61919-279ATENOLOLATENOLOLDirect_RxANDACurrent
61919-664ATENOLOLATENOLOLDirect_RxANDACurrent
61919-664ATENOLOLATENOLOLDirect_RxANDACurrent
61919-664ATENOLOLATENOLOLDirect_RxANDACurrent
61919-664ATENOLOLATENOLOLDirectRXANDACurrent
61919-664ATENOLOLATENOLOLDirect_RxANDACurrent
61919-664ATENOLOLATENOLOLDirect_RxANDACurrent
63187-537AtenololAtenololProficient Rx LPANDACurrent
63187-537AtenololAtenololProficient Rx LPANDACurrent
63187-537AtenololAtenololProficient Rx LPANDACurrent
63187-537AtenololAtenololProficient Rx LPANDACurrent
63187-710AtenololAtenololProficient Rx LPANDACurrent
63187-710AtenololAtenololProficient Rx LPANDACurrent
63187-710AtenololAtenololProficient Rx LPANDACurrent
63629-6443AtenololAtenololBryant Ranch PrepackANDACurrent
63629-6443AtenololAtenololBryant Ranch PrepackANDACurrent