Atenolol

Product NDC
70518-3036
11-digit product format
705183036
Labeler code
70518
Product ID
70518-3036_4b07663b-fc4b-4cad-e063-6294a90a1a8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078512
Marketing category
ANDA
Marketing start
2021-03-03
Substance
ATENOLOL
Active strength
50 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-303670518-3036-2DDiscontinued by firm2026-08-03
excluded packagepackage70518-303670518-3036-3DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0570518-3036-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-3036-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2670518-3036-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-3036-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3170518-3036-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2870518-3036-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2170518-3036-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1070518-3036-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3170518-3036-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2070518-3036-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1070518-3036-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0870518-3036-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0370518-3036-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0970518-3036-2557ba5c1ecfa…9c80585c8c6e…

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
A078512-001ATENOLOLATENOLOL25MGTABLET / ORALAB2007-10-31
A078512-002ATENOLOLATENOLOL50MGTABLET / ORALAB2007-10-31
A078512-003ATENOLOLATENOLOL100MGTABLET / ORALAB2007-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078512-001AB
A078512-002AB
A078512-003AB

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 UTC2026-02A078512-001ATENOLOL25MGTABLET / ORALAB2007-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078512-002ATENOLOL50MGTABLET / ORALAB2007-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078512-003ATENOLOL100MGTABLET / ORALAB2007-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078512-001ATENOLOL25MGTABLET / ORALAB2007-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078512-002ATENOLOL50MGTABLET / ORALAB2007-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078512-003ATENOLOL100MGTABLET / ORALAB2007-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078512-001ATENOLOL25MGTABLET / ORALAB2007-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078512-002ATENOLOL50MGTABLET / ORALAB2007-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078512-003ATENOLOL100MGTABLET / ORALAB2007-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078512-001ATENOLOL25MGTABLET / ORALAB2007-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078512-002ATENOLOL50MGTABLET / ORALAB2007-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078512-003ATENOLOL100MGTABLET / ORALAB2007-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078512-001ATENOLOL25MGTABLET / ORALAB2007-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078512-002ATENOLOL50MGTABLET / ORALAB2007-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078512-003ATENOLOL100MGTABLET / ORALAB2007-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078512-001ATENOLOL25MGTABLET / ORALAB2007-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078512-002ATENOLOL50MGTABLET / ORALAB2007-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078512-003ATENOLOL100MGTABLET / ORALAB2007-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078512-001ATENOLOL25MGTABLET / ORALAB2007-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078512-002ATENOLOL50MGTABLET / ORALAB2007-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078512-003ATENOLOL100MGTABLET / ORALAB2007-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078512-001ATENOLOL25MGTABLET / ORALAB2007-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078512-002ATENOLOL50MGTABLET / ORALAB2007-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078512-003ATENOLOL100MGTABLET / ORALAB2007-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078512-001ATENOLOL25MGTABLET / ORALAB2007-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078512-002ATENOLOL50MGTABLET / ORALAB2007-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078512-003ATENOLOL100MGTABLET / ORALAB2007-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078512-001ATENOLOL25MGTABLET / ORALAB2007-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A078512-002ATENOLOL50MGTABLET / ORALAB2007-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A078512-003ATENOLOL100MGTABLET / ORALAB2007-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078512-001ATENOLOL25MGTABLET / ORALAB2007-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078512-002ATENOLOL50MGTABLET / ORALAB2007-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078512-003ATENOLOL100MGTABLET / ORALAB2007-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078512-001ATENOLOL25MGTABLET / ORALAB2007-10-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078512-002ATENOLOL50MGTABLET / ORALAB2007-10-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078512-003ATENOLOL100MGTABLET / ORALAB2007-10-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078512-001ATENOLOL25MGTABLET / ORALAB2007-10-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078512-002ATENOLOL50MGTABLET / ORALAB2007-10-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078512-003ATENOLOL100MGTABLET / ORALAB2007-10-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078512-001ATENOLOL25MGTABLET / ORALAB2007-10-318072bd15b7f6…

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 UTC2026-02A078512-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078512-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078512-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078512-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078512-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078512-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078512-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078512-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078512-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078512-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078512-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078512-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078512-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078512-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078512-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078512-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078512-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078512-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078512-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078512-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078512-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078512-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078512-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078512-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078512-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078512-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078512-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078512-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078512-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078512-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078512-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078512-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078512-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078512-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078512-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078512-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078512-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078512-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078512-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078512-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Atenolol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATENOLOL50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
50VV3VW0TIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197381Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4ca8dd77-cdac-41fe-a742-b1b32551203bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
faf41ef3-b4b3-a29e-3b26-07c3009003bfProduct name520220517
5eb1a708-d713-e905-0a08-b103c64796f4Product name320201019

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3036-0Atenolol30 in 1 BLISTER PACKTABLET3010
70518-3036-1Atenolol90 in 1 BOTTLE, PLASTICTABLET9010
70518-3036-2Atenolol100 in 1 BOTTLE, PLASTICTABLET10010
70518-3036-3Atenolol30 in 1 BLISTER PACKTABLET3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3036-0EA - Each70518-3036aebf5208-a196-473e-ad8e-21b5ff54088312026-01-08
70518-3036-1EA - Each70518-30366619fd4e-7e09-4d3f-8be2-4a28d0160c7412026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3036ATENOLOL TABLET [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 4 package rows20250409_4ca8dd77-cdac-41fe-a742-b1b32551203b.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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLCoupler LLC5126a70e-632d-e626-e063-6394a90ab7912026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078512
application number: ANDA078512
AtenololATENOLOLCoupler LLC50760735-9305-0bbf-e063-6294a90a5b4c2026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078512
application number: ANDA078512
AtenololATENOLOLCoupler LLC50762eee-e139-4d7f-e063-6294a90a777c2026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078512
application number: ANDA078512
AtenololATENOLOLREMEDYREPACK INC.f5c86a73-70b6-46b2-ad9a-272c8d4673e92026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078512
application number: ANDA078512
AtenololATENOLOLREMEDYREPACK INC.4ca8dd77-cdac-41fe-a742-b1b32551203b2026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078512
application number: ANDA078512
ndc (product): 70518-3036
AtenololATENOLOLNorthwind Health Company, LLCf31b11ed-2ff6-5cfc-e053-2a95a90af2ca2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078512
application number: ANDA078512
AtenololATENOLOLNorthwind Health Company, LLCf76d03b8-f8d6-59b8-e053-6394a90a3a3f2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078512
application number: ANDA078512
AtenololATENOLOLNorthwind Health Company, LLCf2b335b4-93d2-0459-e053-2a95a90a1a5b2025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078512
application number: ANDA078512
AtenololATENOLOLQPharma Incf682a775-2255-05e2-e053-2a95a90ac3f32025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078512
application number: ANDA078512
AtenololATENOLOLNuCare Pharmaceuticals,Inc.331128cc-f56e-4329-e063-6394a90a5ead2025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078512
application number: ANDA078512
AtenololATENOLOLNuCare Pharmaceuticals,Inc.410c48ae-582a-2ab2-e063-6294a90af27c2025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078512
application number: ANDA078512
AtenololATENOLOLREMEDYREPACK INC.cdca0ef8-2ac3-4430-a662-f88522f68d8e2025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078512
application number: ANDA078512
AtenololATENOLOLPreferred Pharmaceuticals Inc.0f744371-94fa-419d-bfed-b22301dde8b82025-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078512
application number: ANDA078512
AtenololATENOLOLMajor Pharmaceuticals4555261d-a997-4aa5-aba8-81aac70337872025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078512
application number: ANDA078512
AtenololATENOLOLBryant Ranch Prepack09b21985-1818-449d-9b29-98f733cf7b9f2024-11-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078512
application number: ANDA078512
AtenololATENOLOLPreferred Pharmaceuticals Inc.2ae158bb-aa03-4b44-916b-1fcfc84b4fd02024-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078512
application number: ANDA078512
AtenololATENOLOLAurobindo Pharma Limited1b8a4689-3916-4f4b-b54a-bbb4e322d79b2024-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078512
application number: ANDA078512
AtenololATENOLOLA-S Medication Solutionsa0e3b2a5-5ea1-4549-8144-bd059f7966f02023-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078512
application number: ANDA078512
AtenololATENOLOLA-S Medication Solutions98471493-56ee-47a4-9120-0975c265361e2023-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078512
application number: ANDA078512

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197381atenolol 50 MG Oral TabletPSN4ca8dd77-cdac-41fe-a742-b1b32551203b10
197381atenolol 50 MG Oral TabletSCD4ca8dd77-cdac-41fe-a742-b1b32551203b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3036-07051830360030 TABLET in 1 BLISTER PACK (70518-3036-0) 30 tablet2021-03-030000-00-00NoNoCurrent
70518-3036-17051830360190 TABLET in 1 BOTTLE, PLASTIC (70518-3036-1) 90 tablet2021-03-120000-00-00NoNoCurrent
70518-3036-270518303602100 TABLET in 1 BOTTLE, PLASTIC (70518-3036-2) 100 tablet2021-06-160000-00-00NoNoCurrent
70518-3036-37051830360330 TABLET in 1 BLISTER PACK (70518-3036-3) 30 tablet2022-08-160000-00-00NoNoCurrent