Atenolol

Product NDC
29300-411
11-digit product format
293000411
Labeler code
29300
Product ID
29300-411_b84110b2-cefb-49d0-8b08-1057dbdc258b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA213136
Marketing category
ANDA
Marketing start
2019-11-21
Substance
ATENOLOL
Active strength
50 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A213136-001ATENOLOLATENOLOL25MGTABLET / ORALAB2019-11-21
A213136-002ATENOLOLATENOLOL50MGTABLET / ORALAB2019-11-21
A213136-003ATENOLOLATENOLOL100MGTABLET / ORALAB2019-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213136-001AB
A213136-002AB
A213136-003AB

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 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213136-001ATENOLOL25MGTABLET / ORALAB2019-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213136-002ATENOLOL50MGTABLET / ORALAB2019-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213136-003ATENOLOL100MGTABLET / ORALAB2019-11-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213136-001ATENOLOL25MGTABLET / ORALAB2019-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213136-002ATENOLOL50MGTABLET / ORALAB2019-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213136-003ATENOLOL100MGTABLET / ORALAB2019-11-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213136-001ATENOLOL25MGTABLET / ORALAB2019-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213136-002ATENOLOL50MGTABLET / ORALAB2019-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213136-003ATENOLOL100MGTABLET / ORALAB2019-11-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213136-001ATENOLOL25MGTABLET / ORALAB2019-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213136-002ATENOLOL50MGTABLET / ORALAB2019-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213136-003ATENOLOL100MGTABLET / ORALAB2019-11-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213136-001ATENOLOL25MGTABLET / ORALAB2019-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213136-002ATENOLOL50MGTABLET / ORALAB2019-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213136-003ATENOLOL100MGTABLET / ORALAB2019-11-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213136-001ATENOLOL25MGTABLET / ORALAB2019-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213136-002ATENOLOL50MGTABLET / ORALAB2019-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213136-003ATENOLOL100MGTABLET / ORALAB2019-11-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213136-001ATENOLOL25MGTABLET / ORALAB2019-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213136-002ATENOLOL50MGTABLET / ORALAB2019-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213136-003ATENOLOL100MGTABLET / ORALAB2019-11-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213136-001ATENOLOL25MGTABLET / ORALAB2019-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213136-002ATENOLOL50MGTABLET / ORALAB2019-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213136-003ATENOLOL100MGTABLET / ORALAB2019-11-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213136-001ATENOLOL25MGTABLET / ORALAB2019-11-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213136-002ATENOLOL50MGTABLET / ORALAB2019-11-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213136-003ATENOLOL100MGTABLET / ORALAB2019-11-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213136-001ATENOLOL25MGTABLET / ORALAB2019-11-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A213136-002ATENOLOL50MGTABLET / ORALAB2019-11-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A213136-003ATENOLOL100MGTABLET / ORALAB2019-11-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213136-001ATENOLOL25MGTABLET / ORALAB2019-11-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213136-002ATENOLOL50MGTABLET / ORALAB2019-11-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213136-003ATENOLOL100MGTABLET / ORALAB2019-11-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213136-001ATENOLOL25MGTABLET / ORALAB2019-11-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213136-002ATENOLOL50MGTABLET / ORALAB2019-11-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213136-003ATENOLOL100MGTABLET / ORALAB2019-11-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213136-001ATENOLOL25MGTABLET / ORALAB2019-11-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213136-002ATENOLOL50MGTABLET / ORALAB2019-11-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213136-003ATENOLOL100MGTABLET / ORALAB2019-11-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213136-001ATENOLOL25MGTABLET / ORALAB2019-11-218072bd15b7f6…

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
2026-02-19 14:30 UTC2026-02A213136-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213136-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213136-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213136-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213136-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213136-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213136-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213136-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213136-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213136-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213136-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213136-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213136-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213136-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213136-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213136-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213136-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213136-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213136-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213136-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213136-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213136-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213136-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213136-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213136-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213136-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213136-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213136-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213136-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213136-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213136-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213136-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213136-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213136-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213136-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213136-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213136-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213136-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213136-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213136-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Atenolol
Listing expiration
2026-12-31

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
35d99c43-7305-4a4a-886e-a9bf3ee88fa8Available 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
29300-411-01Atenolol100 in 1 BOTTLETABLET1006
29300-411-05Atenolol500 in 1 BOTTLETABLET5006
29300-411-10Atenolol1000 in 1 BOTTLETABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-411-10EA - Each29300-4119dccc851-a30f-4dd1-9de5-4af9b415e3c312022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-411ATENOLOL TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]6Current NDC, Legacy NDC, 3 package rows20240123_35d99c43-7305-4a4a-886e-a9bf3ee88fa8.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLASCLEMED USA INC.2ee7b7da-303d-4a57-a1eb-25e8923660c02026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213136
application number: ANDA213136
AtenololATENOLOLPreferred Pharmaceuticals Inc.0ad0c7dd-e4e5-4968-9372-7a9bb30073ec2026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213136
application number: ANDA213136
AtenololATENOLOLPreferred Pharmaceuticals Inc.5ad1426a-5a74-427b-812d-c7b144c844742026-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213136
application number: ANDA213136
AtenololATENOLOLA-S Medication Solutionsd7a93c64-0c52-4d72-a9be-37c7ca355cdf2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213136
application number: ANDA213136
AtenololATENOLOLBryant Ranch Prepack290f4de3-8815-466c-81dc-8bc6323758962025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213136
application number: ANDA213136
AtenololATENOLOLREMEDYREPACK INC.897e18f6-3b57-4ef0-85ff-9dfa23521eb92025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213136
application number: ANDA213136
AtenololATENOLOLA-S Medication Solutions3d35592c-91ac-44f6-b077-5963e952f0dd2025-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213136
application number: ANDA213136
AtenololATENOLOLA-S Medication Solutionsf419c72e-f1f9-4b5a-94ff-a525367cdce42025-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213136
application number: ANDA213136
AtenololATENOLOLA-S Medication Solutionsd3e72119-e3c3-41ba-8787-acc86b44d6c42025-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213136
application number: ANDA213136
AtenololATENOLOLA-S Medication Solutionsa3c8d507-e040-409e-9f97-742925cc66a12025-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213136
application number: ANDA213136
Atenolol 29300-411ATENOLOLNuCare Pharmaceuticals,Inc.239b1cce-3b1a-f049-e063-6394a90a0e0a2024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213136
application number: ANDA213136
AtenololATENOLOLQuality Care Products, LLC4fc4a969-286f-4fd2-b16a-f0291fd1c5c02024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213136
application number: ANDA213136
AtenololATENOLOLBryant Ranch Prepackbd0f7f1c-dd20-4de6-a012-f581a216f23f2024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213136
application number: ANDA213136
AtenololATENOLOLUnichem Pharmaceuticals (USA), Inc.35d99c43-7305-4a4a-886e-a9bf3ee88fa82024-01-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213136
application number: ANDA213136
ndc (product): 29300-411

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197381atenolol 50 MG Oral TabletPSNd3e72119-e3c3-41ba-8787-acc86b44d6c49
197381atenolol 50 MG Oral TabletSCDd3e72119-e3c3-41ba-8787-acc86b44d6c49
197379atenolol 100 MG Oral TabletPSN35d99c43-7305-4a4a-886e-a9bf3ee88fa86
197380atenolol 25 MG Oral TabletPSN35d99c43-7305-4a4a-886e-a9bf3ee88fa86
197381atenolol 50 MG Oral TabletPSN35d99c43-7305-4a4a-886e-a9bf3ee88fa86
197379atenolol 100 MG Oral TabletSCD35d99c43-7305-4a4a-886e-a9bf3ee88fa86
197380atenolol 25 MG Oral TabletSCD35d99c43-7305-4a4a-886e-a9bf3ee88fa86
197381atenolol 50 MG Oral TabletSCD35d99c43-7305-4a4a-886e-a9bf3ee88fa86
197381atenolol 50 MG Oral TabletPSNa3c8d507-e040-409e-9f97-742925cc66a14
197381atenolol 50 MG Oral TabletSCDa3c8d507-e040-409e-9f97-742925cc66a14
197381atenolol 50 MG Oral TabletPSN4fc4a969-286f-4fd2-b16a-f0291fd1c5c03
197381atenolol 50 MG Oral TabletSCD4fc4a969-286f-4fd2-b16a-f0291fd1c5c03
197381atenolol 50 MG Oral TabletPSN239b1cce-3b1a-f049-e063-6394a90a0e0a2
197381atenolol 50 MG Oral TabletSCD239b1cce-3b1a-f049-e063-6394a90a0e0a2
197379atenolol 100 MG Oral TabletPSN2ee7b7da-303d-4a57-a1eb-25e8923660c01
197380atenolol 25 MG Oral TabletPSN2ee7b7da-303d-4a57-a1eb-25e8923660c01
197381atenolol 50 MG Oral TabletPSN2ee7b7da-303d-4a57-a1eb-25e8923660c01
197379atenolol 100 MG Oral TabletSCD2ee7b7da-303d-4a57-a1eb-25e8923660c01
197380atenolol 25 MG Oral TabletSCD2ee7b7da-303d-4a57-a1eb-25e8923660c01
197381atenolol 50 MG Oral TabletSCD2ee7b7da-303d-4a57-a1eb-25e8923660c01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-411-0129300041101100 TABLET in 1 BOTTLE (29300-411-01) 100 tablet2020-01-060000-00-00NoNoCurrent
29300-411-0529300041105500 TABLET in 1 BOTTLE (29300-411-05) 500 tablet2020-01-060000-00-00NoNoCurrent
29300-411-10293000411101000 TABLET in 1 BOTTLE (29300-411-10) 1000 tablet2022-08-260000-00-00NoNoCurrent