Atenolol

Product NDC
13107-169
11-digit product format
131070169
Labeler code
13107
Product ID
13107-169_b72f170e-bfa6-463c-9345-31f8a37e43e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Aurolife Pharma LLC
Application
ANDA078512
Marketing category
ANDA
Marketing start
2011-06-20
Marketing end
0000-00-00
Substance
ATENOLOL
Active strength
50 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct13107-169IInactivated by FDA2026-08-03
excluded packagepackage13107-16913107-169-01IInactivated by FDA2026-08-03
excluded packagepackage13107-16913107-169-99IInactivated by FDA2026-08-03

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13107-169-99d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13107-169-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13107-169-99f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13107-169-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13107-169-992ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13107-169-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13107-169-99a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13107-169-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13107-169-99cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13107-169-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13107-169-99cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13107-169-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13107-169-99302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13107-169-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13107-169-99ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13107-169-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13107-169-990efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13107-169-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13107-169-99ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13107-169-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13107-169-99367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13107-169-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13107-169-99557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13107-169-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage13107-169-998af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage13107-169-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage13107-169-99834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage13107-169-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage13107-169-991332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage13107-169-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage13107-169-99fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage13107-169-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage13107-169-9986f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage13107-169-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage13107-169-99bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage13107-169-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage13107-169-998dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage13107-169-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage13107-169-99e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage13107-169-01e2bbac7714bc…27bdfed8d636…

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…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13107-169-012019-10-29C16284748780-1960f7f55-c2e7-8e05-e053-dbdaa90a074aAtenolol Tablets, USP Rx only
13107-169-992019-10-29C16284748780-1960f7f55-c2e7-8e05-e053-dbdaa90a074aAtenolol Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-169-01Atenolol100 in 1 BOTTLETABLET1003
13107-169-99Atenolol1000 in 1 BOTTLETABLET10003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [AUROLIFE PHARMA LLC]3
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [AUROLIFE PHARMA LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [AUROLIFE PHARMA LLC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKATENOLOL TABLET [AUROLIFE PHARMA LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [AUROLIFE PHARMA LLC]3
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZATENOLOL TABLET [AUROLIFE PHARMA LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [AUROLIFE PHARMA LLC]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [AUROLIFE PHARMA LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-169ATENOLOL TABLET [AUROLIFE PHARMA LLC]3Legacy NDC, 2 package rows20110706_308c0bb7-e8cc-4920-8f23-cf8e7c004341.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
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
197379atenolol 100 MG Oral TabletPSN308c0bb7-e8cc-4920-8f23-cf8e7c0043413
197380atenolol 25 MG Oral TabletPSN308c0bb7-e8cc-4920-8f23-cf8e7c0043413
197381atenolol 50 MG Oral TabletPSN308c0bb7-e8cc-4920-8f23-cf8e7c0043413
197379atenolol 100 MG Oral TabletSCD308c0bb7-e8cc-4920-8f23-cf8e7c0043413
197380atenolol 25 MG Oral TabletSCD308c0bb7-e8cc-4920-8f23-cf8e7c0043413
197381atenolol 50 MG Oral TabletSCD308c0bb7-e8cc-4920-8f23-cf8e7c0043413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
13107-169-0113107016901100 in 1 BOTTLEHistorical
13107-169-99131070169991000 in 1 BOTTLEHistorical