Atenolol

Product NDC
83980-023
11-digit product format
839800023
Labeler code
83980
Product ID
83980-023_d32b777e-6c64-4899-934b-4fb73d9eba85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Ipca Laboratories Limited
Application
ANDA077877
Marketing category
ANDA
Marketing start
2007-12-04
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

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
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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077877-001ATENOLOL25MGTABLET / 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…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077877-002ATENOLOL50MGTABLET / ORALAB2006-12-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077877-003ATENOLOL100MGTABLET / ORALAB2006-12-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077877-001ATENOLOL25MGTABLET / ORALAB2006-12-27301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2022-04-08 23:34 UTC2022-04A077877-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077877-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077877-001AB14b0b4de00fa7…

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
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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197379Internal RxNorm lookup
197380Internal RxNorm lookup
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
98d29958-b026-4888-a516-7bb85bb7d479Available 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
83980-023-01Atenolol100 in 1 BOTTLETABLET1001
83980-023-10Atenolol1000 in 1 BOTTLETABLET10001
83980-023-97Atenolol10 in 1 BOTTLETABLET101

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
ndc (product): 83980-023

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197379atenolol 100 MG Oral TabletPSN98d29958-b026-4888-a516-7bb85bb7d4791
197380atenolol 25 MG Oral TabletPSN98d29958-b026-4888-a516-7bb85bb7d4791
197381atenolol 50 MG Oral TabletPSN98d29958-b026-4888-a516-7bb85bb7d4791
197379atenolol 100 MG Oral TabletSCD98d29958-b026-4888-a516-7bb85bb7d4791
197380atenolol 25 MG Oral TabletSCD98d29958-b026-4888-a516-7bb85bb7d4791
197381atenolol 50 MG Oral TabletSCD98d29958-b026-4888-a516-7bb85bb7d4791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83980-023-0183980002301100 TABLET in 1 BOTTLE (83980-023-01) 100 tablet2026-01-30NoNoCurrent
83980-023-10839800023101000 TABLET in 1 BOTTLE (83980-023-10) 1000 tablet2026-01-30NoNoCurrent
83980-023-978398000239710 TABLET in 1 BOTTLE (83980-023-97) 10 tablet2026-01-30NoNoCurrent