Atenolol

Product NDC
71335-3178
Requested package NDC
71335-3178-1
11-digit product format
713353178
Labeler code
71335
Product ID
71335-3178_3aca509f-111d-4965-80f8-fefea17005b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077877
Marketing category
ANDA
Marketing start
2007-12-04
Substance
ATENOLOL
Active strength
100 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A077877-001ATENOLOLATENOLOL25MGTABLET / ORALAB2006-12-27
A077877-002ATENOLOLATENOLOL50MGTABLET / ORALAB2006-12-27
A077877-003ATENOLOLATENOLOL100MGTABLET / ORALAB2006-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077877-001AB
A077877-002AB
A077877-003AB

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A077877-001ATENOLOL25MGTABLET / ORALAB2006-12-27c2088c7a36db…
2026-10-15 13:18:302026-09A077877-002ATENOLOL50MGTABLET / ORALAB2006-12-27c2088c7a36db…
2026-10-15 13:18:302026-09A077877-003ATENOLOL100MGTABLET / ORALAB2006-12-27c2088c7a36db…
2026-09-14 22:38:342026-08A077877-001ATENOLOL25MGTABLET / ORALAB2006-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A077877-002ATENOLOL50MGTABLET / ORALAB2006-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A077877-003ATENOLOL100MGTABLET / ORALAB2006-12-2784e616aacf4f…
2026-08-18 06:07:402026-07A077877-001ATENOLOL25MGTABLET / ORALAB2006-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A077877-002ATENOLOL50MGTABLET / ORALAB2006-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A077877-003ATENOLOL100MGTABLET / ORALAB2006-12-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077877-001ATENOLOL25MGTABLET / ORALAB2006-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077877-002ATENOLOL50MGTABLET / ORALAB2006-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077877-003ATENOLOL100MGTABLET / ORALAB2006-12-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077877-001ATENOLOL25MGTABLET / ORAL2006-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077877-002ATENOLOL50MGTABLET / ORAL2006-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077877-003ATENOLOL100MGTABLET / ORAL2006-12-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077877-001ATENOLOL25MGTABLET / ORAL2006-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077877-002ATENOLOL50MGTABLET / ORAL2006-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077877-003ATENOLOL100MGTABLET / ORAL2006-12-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077877-001ATENOLOL25MGTABLET / ORAL2006-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077877-002ATENOLOL50MGTABLET / ORAL2006-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077877-003ATENOLOL100MGTABLET / ORAL2006-12-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077877-001ATENOLOL25MGTABLET / ORAL2006-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077877-002ATENOLOL50MGTABLET / ORAL2006-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077877-003ATENOLOL100MGTABLET / ORAL2006-12-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077877-001ATENOLOL25MGTABLET / ORAL2006-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077877-002ATENOLOL50MGTABLET / ORAL2006-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077877-003ATENOLOL100MGTABLET / ORAL2006-12-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077877-001ATENOLOL25MGTABLET / ORALAB2006-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077877-002ATENOLOL50MGTABLET / ORALAB2006-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077877-003ATENOLOL100MGTABLET / ORALAB2006-12-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077877-001ATENOLOL25MGTABLET / ORALAB2006-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077877-002ATENOLOL50MGTABLET / ORALAB2006-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077877-003ATENOLOL100MGTABLET / ORALAB2006-12-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077877-001ATENOLOL25MGTABLET / ORALAB2006-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077877-002ATENOLOL50MGTABLET / ORALAB2006-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077877-003ATENOLOL100MGTABLET / ORALAB2006-12-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077877-001ATENOLOL25MGTABLET / ORALAB2006-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A077877-002ATENOLOL50MGTABLET / ORALAB2006-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A077877-003ATENOLOL100MGTABLET / ORALAB2006-12-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077877-001ATENOLOL25MGTABLET / ORALAB2006-12-2779d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A077877-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A077877-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A077877-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A077877-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077877-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077877-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A077877-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077877-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077877-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077877-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077877-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077877-003AB1011fe1cb6892…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077877-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077877-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077877-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077877-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077877-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077877-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077877-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077877-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077877-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077877-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077877-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077877-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077877-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077877-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077877-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077877-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077877-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077877-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077877-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077877-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077877-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077877-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077877-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077877-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077877-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077877-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077877-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077877-001AB15d02ea3f76ae…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATENOLOL100 mg/1

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLIpca Laboratories Limited98d29958-b026-4888-a516-7bb85bb7d4792026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077877
application number: ANDA077877

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3178-171335317801100 TABLET in 1 BOTTLE (71335-3178-1) 100 tablet2026-09-24NoNoCurrent