Atenolol

Product NDC
67544-326
11-digit product format
675440326
Labeler code
67544
Product ID
67544-326_045a1d78-1ac0-4f65-958e-8777ab4b1cf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA074056
Marketing category
ANDA
Marketing start
1995-02-22
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
No
Listing certified through
2019-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67544-326IInactivated by FDA2026-10-05
excluded packagepackage67544-32667544-326-15IInactivated by FDA2026-10-05
excluded packagepackage67544-32667544-326-30IInactivated by FDA2026-10-05
excluded packagepackage67544-32667544-326-45IInactivated by FDA2026-10-05
excluded packagepackage67544-32667544-326-60IInactivated by FDA2026-10-05
excluded packagepackage67544-32667544-326-73IInactivated by FDA2026-10-05
excluded packagepackage67544-32667544-326-80IInactivated by FDA2026-10-05

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 · 147 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 packagepackage67544-326-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-326-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-326-73d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-326-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-326-80d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-326-45d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-326-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-326-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-326-73f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-326-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-326-80f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-326-45f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-326-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-326-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-326-732ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-326-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-326-802ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-326-452ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-326-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-326-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-326-73a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-326-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-326-80a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-326-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-326-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-326-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-326-73cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-326-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-326-80cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-326-45cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-326-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-326-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-326-73cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-326-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-326-80cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-326-45cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-326-15302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-326-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-326-73302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-326-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-326-80302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-326-45302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-326-15ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-326-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-326-73ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-326-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-326-80ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-326-45ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67544-326-150efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67544-326-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67544-326-730efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-1884e616aacf4f…
2026-09-14 22:38:342026-08A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-1884e616aacf4f…
2026-09-14 22:38:342026-08A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-1984e616aacf4f…
2026-08-18 06:07:402026-07A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A074056-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A074056-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A074056-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A074056-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074056-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074056-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074056-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074056-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074056-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074056-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074056-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074056-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074056-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074056-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074056-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-326-15Atenolol15 in 1 BOTTLE, PLASTICTABLET151
67544-326-30Atenolol30 in 1 BOTTLE, PLASTICTABLET301
67544-326-45Atenolol45 in 1 BOTTLE, PLASTICTABLET451
67544-326-60Atenolol90 in 1 BOTTLE, PLASTICTABLET901
67544-326-73Atenolol135 in 1 BOTTLE, PLASTICTABLET1351
67544-326-80Atenolol180 in 1 BOTTLE, PLASTICTABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-326-15EA - Each67544-326c40ee760-13cd-4f4f-b5da-b4224b9d16de12014-06-03
67544-326-30EA - Each67544-32670fdd0ca-2f27-46ae-8961-a85ad866018312014-06-03
67544-326-45EA - Each67544-3263ca31f0b-ae60-45a8-a041-44424278793a12014-06-03
67544-326-60EA - Each67544-3262765ec4e-dabd-44f6-b9b3-c1f421247a8312014-06-03
67544-326-73EA - Each67544-326e8a02c58-835e-4773-ab86-485f007b3f6712014-06-03
67544-326-80EA - Each67544-3266fe77629-3869-43b0-ad41-73f03a28a85c12014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-326ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 6 package rows20140516_28ea6fb6-11e5-4bfe-b169-41c8aeaab705.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 · 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
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.95761173-1c95-46b2-a08f-fbc3e70daba82025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.c69b8e5e-c7c3-4883-9cea-f7f435a8ede82025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
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
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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197381atenolol 50 MG Oral TabletPSN28ea6fb6-11e5-4bfe-b169-41c8aeaab7051
197381atenolol 50 MG Oral TabletSCD28ea6fb6-11e5-4bfe-b169-41c8aeaab7051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67544-326-156754403261515 in 1 BOTTLE, PLASTICHistorical
67544-326-306754403263030 in 1 BOTTLE, PLASTICHistorical
67544-326-456754403264545 in 1 BOTTLE, PLASTICHistorical
67544-326-606754403266090 in 1 BOTTLE, PLASTICHistorical
67544-326-7367544032673135 in 1 BOTTLE, PLASTICHistorical
67544-326-8067544032680180 in 1 BOTTLE, PLASTICHistorical