Atenolol and Chlorthalidone

Product NDC
53489-531
11-digit product format
534890531
Labeler code
53489
Product ID
53489-531_86da35ec-fbfa-4474-bf4b-a58d9c737a19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol and Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Mutual Pharmaceutical Company, Inc.
Application
ANDA073582
Marketing category
ANDA
Marketing start
1993-04-29
Marketing end
0000-00-00
Substance
ATENOLOL; CHLORTHALIDONE
Active strength
50 mg/1; mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Thiazide-like Diuretic [EPC],Increased Diuresis [PE]
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53489-531IInactivated by FDA2026-09-09
excluded packagepackage53489-53153489-531-01IInactivated by FDA2026-09-09
excluded packagepackage53489-53153489-531-02IInactivated by FDA2026-09-09
excluded packagepackage53489-53153489-531-03IInactivated by FDA2026-09-09
excluded packagepackage53489-53153489-531-05IInactivated by FDA2026-09-09
excluded packagepackage53489-53153489-531-10IInactivated by FDA2026-09-09

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 3 · 132 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 packagepackage53489-531-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53489-531-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53489-531-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53489-531-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53489-531-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53489-531-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53489-531-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53489-531-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53489-531-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53489-531-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53489-531-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53489-531-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53489-531-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53489-531-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53489-531-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53489-531-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53489-531-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53489-531-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53489-531-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53489-531-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53489-531-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53489-531-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53489-531-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53489-531-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53489-531-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53489-531-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53489-531-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53489-531-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53489-531-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53489-531-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53489-531-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53489-531-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53489-531-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53489-531-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53489-531-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53489-531-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53489-531-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53489-531-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53489-531-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53489-531-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53489-531-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53489-531-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53489-531-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53489-531-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53489-531-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53489-531-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53489-531-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53489-531-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53489-531-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53489-531-10ad56d346431e…cc804d4bbf1e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A073582-001ATENOLOL AND CHLORTHALIDONEATENOLOL; CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-29
A073582-002ATENOLOL AND CHLORTHALIDONEATENOLOL; CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-29

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073582-001ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-04-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A073582-002ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-04-29bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A073582-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A073582-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A073582-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A073582-002AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83fe98fe-2a14-448c-9029-41f7600d1b0aProduct name120260105
0450926f-f624-49c2-83be-42807e8fbcd5Product name120251113
8525e779-537f-e5cc-2515-089ecce5f50fProduct name920221128
faf41ef3-b4b3-a29e-3b26-07c3009003bfProduct name520220517
5eb1a708-d713-e905-0a08-b103c64796f4Product name320201019
3f5e2da3-8b99-f714-3261-2c998ee07b05Product name120140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53489-531-01Atenolol and Chlorthalidone100 in 1 BOTTLE, PLASTICTABLET1004
53489-531-02Atenolol and Chlorthalidone50 in 1 BOTTLE, PLASTICTABLET504
53489-531-03Atenolol and Chlorthalidone250 in 1 BOTTLE, PLASTICTABLET2504
53489-531-05Atenolol and Chlorthalidone500 in 1 BOTTLE, PLASTICTABLET5004
53489-531-10Atenolol and Chlorthalidone1000 in 1 BOTTLE, PLASTICTABLET10004

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-531ATENOLOL AND CHLORTHALIDONE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]4Legacy NDC, 5 package rows20130103_b4cfa459-c1c3-4fe2-ac2d-afeea2b96cca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197382atenolol 100 MG / chlorthalidone 25 MG Oral TabletPSNb4cfa459-c1c3-4fe2-ac2d-afeea2b96cca4
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletPSNb4cfa459-c1c3-4fe2-ac2d-afeea2b96cca4
197382atenolol 100 MG / chlorthalidone 25 MG Oral TabletSCDb4cfa459-c1c3-4fe2-ac2d-afeea2b96cca4
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletSCDb4cfa459-c1c3-4fe2-ac2d-afeea2b96cca4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53489-531-0153489053101100 in 1 BOTTLE, PLASTICHistorical
53489-531-025348905310250 in 1 BOTTLE, PLASTICHistorical
53489-531-0353489053103250 in 1 BOTTLE, PLASTICHistorical
53489-531-0553489053105500 in 1 BOTTLE, PLASTICHistorical
53489-531-10534890531101000 in 1 BOTTLE, PLASTICHistorical