Atenolol

Product NDC
50090-5363
11-digit product format
500905363
Labeler code
50090
Product ID
50090-5363_7c899e6b-8077-4970-93cb-ff9b374beef9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-536350090-5363-4DDiscontinued by firm2026-08-03

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 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-536350090-5363-4DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-536350090-5363-4DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
d3e72119-e3c3-41ba-8787-acc86b44d6c4Available 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
50090-5363-0Atenolol100 in 1 BOTTLETABLET1009
50090-5363-1Atenolol30 in 1 BOTTLETABLET309
50090-5363-4Atenolol60 in 1 BOTTLETABLET609
50090-5363-7Atenolol200 in 1 BOTTLETABLET2009
50090-5363-8Atenolol90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5363-0EA - Each50090-536373775bce-85de-4276-b5bb-aa343050bf9712022-12-07
50090-5363-1EA - Each50090-5363f31e0015-ef21-49e8-a1dd-04b5a7abe7ed12022-12-07
50090-5363-4EA - Each50090-5363ab3fb034-23bc-4f69-ad9c-4fb842ed341312022-12-07
50090-5363-7EA - Each50090-53632f86f646-2222-4d81-94ef-3ab1cf5b564f12022-11-07
50090-5363-8EA - Each50090-5363a3dabab7-e24d-4ce4-b973-237c9ec0ba0312022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5363ATENOLOL TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 5 package rows20231217_d3e72119-e3c3-41ba-8787-acc86b44d6c4.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
ndc (product): 50090-5363
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5363-050090536300100 TABLET in 1 BOTTLE (50090-5363-0) 100 tablet2020-11-170000-00-00NoNoCurrent
50090-5363-15009053630130 TABLET in 1 BOTTLE (50090-5363-1) 30 tablet2022-10-190000-00-00NoNoCurrent
50090-5363-45009053630460 TABLET in 1 BOTTLE (50090-5363-4) 60 tablet2022-10-190000-00-00NoNoCurrent
50090-5363-750090536307200 TABLET in 1 BOTTLE (50090-5363-7) 200 tablet2020-11-170000-00-00NoNoCurrent
50090-5363-85009053630890 TABLET in 1 BOTTLE (50090-5363-8) 90 tablet2020-11-170000-00-00NoNoCurrent