Atenolol and Chlorthalidone

Product NDC
55289-993
11-digit product format
552890993
Labeler code
55289
Product ID
55289-993_419b8a9a-2ee9-ef30-e063-6294a90a3e94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol and Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA073665
Marketing category
ANDA
Marketing start
1992-08-01
Substance
ATENOLOL; CHLORTHALIDONE
Active strength
50; 25 mg/1; mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide-like Diuretic [EPC], 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A073665-001ATENOLOL AND CHLORTHALIDONEATENOLOL; CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-02
A073665-002ATENOLOL AND CHLORTHALIDONEATENOLOL; CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A073665-001AB
A073665-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073665-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORALAB1992-07-02782e0a99824c…
2021-12-28 21:50 UTC2021-12A073665-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORALAB1992-07-02782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A073665-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073665-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073665-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073665-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A073665-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073665-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073665-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073665-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073665-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073665-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073665-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073665-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073665-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073665-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073665-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073665-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073665-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073665-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073665-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A073665-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073665-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073665-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073665-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073665-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073665-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073665-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073665-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A073665-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073665-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073665-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073665-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A073665-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073665-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A073665-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073665-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A073665-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073665-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A073665-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073665-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A073665-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATENOLOL50 mg/1
CHLORTHALIDONE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
50VV3VW0TIInternal UNII lookup
Q0MQD1073QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197383Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
78b374f8-0e16-4c15-85c1-16609ac3aca2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83fe98fe-2a14-448c-9029-41f7600d1b0aProduct name120260105
0450926f-f624-49c2-83be-42807e8fbcd5Product name120251113
8525e779-537f-e5cc-2515-089ecce5f50fProduct name920221128
faf41ef3-b4b3-a29e-3b26-07c3009003bfProduct name520220517
5eb1a708-d713-e905-0a08-b103c64796f4Product name320201019
3f5e2da3-8b99-f714-3261-2c998ee07b05Product name120140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55289-993-30Atenolol and Chlorthalidone30 in 1 BOTTLE, PLASTICTABLET3020
55289-993-60Atenolol and Chlorthalidone60 in 1 BOTTLE, PLASTICTABLET6020
55289-993-90Atenolol and Chlorthalidone90 in 1 BOTTLE, PLASTICTABLET9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-993-30EA - Each55289-993f6e465a0-3e1f-45e0-9924-3f3aaebb77e012012-07-24
55289-993-60EA - Each55289-99347b72f7b-e8d6-4a2a-a121-be629e5a2fb712012-07-24
55289-993-90EA - Each55289-9938016d6ae-9593-43ea-82c0-f28a42b80ff312012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-993ATENOLOL AND CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]19Current NDC, Legacy NDC, 3 package rows20241006_78b374f8-0e16-4c15-85c1-16609ac3aca2.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atenolol and ChlorthalidoneATENOLOL AND CHLORTHALIDONEPD-Rx Pharmaceuticals, Inc.78b374f8-0e16-4c15-85c1-16609ac3aca22025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073665
application number: ANDA073665
ndc (product): 55289-993
Atenolol and ChlorthalidoneATENOLOL AND CHLORTHALIDONEActavis Pharma, Inc.a6794dfa-adbb-491b-9d48-f89a44e866c52024-03-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073665
application number: ANDA073665

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletPSN78b374f8-0e16-4c15-85c1-16609ac3aca220
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletSCD78b374f8-0e16-4c15-85c1-16609ac3aca220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-993-305528909933030 TABLET in 1 BOTTLE, PLASTIC (55289-993-30) 30 tablet1996-04-240000-00-00NoNoCurrent
55289-993-605528909936060 TABLET in 1 BOTTLE, PLASTIC (55289-993-60) 60 tablet2000-05-080000-00-00NoNoCurrent
55289-993-905528909939090 TABLET in 1 BOTTLE, PLASTIC (55289-993-90) 90 tablet2009-05-180000-00-00NoNoCurrent