FDA.reportPublic FDA data

Atenolol and Chlorthalidone

Product NDC
0591-5782
11-digit product format
005915782
Labeler code
0591
Product ID
0591-5782_b15eb43d-d93a-4e5f-b113-bc256779a40d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol and Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, 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

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 Identifiers#

Field, Values table
FieldValues
UniiQ0MQD1073Q, 50VV3VW0TI
Rxcui197382, 197383

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
0591-5782-01Atenolol and Chlorthalidone100 in 1 BOTTLETABLET10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-5782-01EA - Each0591-5782f136f95e-0bdf-46b5-ad57-611bd753b3f312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL AND CHLORTHALIDONE TABLET [WATSON LABORATORIES, INC.]9
CHLORTHALIDONEACTIVE INGREDIENTQ0MQD1073QATENOLOL AND CHLORTHALIDONE TABLET [WATSON LABORATORIES, INC.]9
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL AND CHLORTHALIDONE TABLET [WATSON LABORATORIES, INC.]9
CHLORTHALIDONEACTIVE MOIETYQ0MQD1073QATENOLOL AND CHLORTHALIDONE TABLET [WATSON LABORATORIES, INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL AND CHLORTHALIDONE TABLET [WATSON LABORATORIES, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL AND CHLORTHALIDONE TABLET [WATSON LABORATORIES, INC.]9
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQATENOLOL AND CHLORTHALIDONE TABLET [WATSON LABORATORIES, INC.]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL AND CHLORTHALIDONE TABLET [WATSON LABORATORIES, INC.]9
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL AND CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]6
CHLORTHALIDONEACTIVE INGREDIENTQ0MQD1073QATENOLOL AND CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]6
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL AND CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]6
CHLORTHALIDONEACTIVE MOIETYQ0MQD1073QATENOLOL AND CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL AND CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL AND CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]6
POVIDONEINACTIVE INGREDIENTFZ989GH94EATENOLOL AND CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL AND CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]6
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.]1
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL AND CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL AND CHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]1
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL AND CHLORTHALIDONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CHLORTHALIDONEACTIVE INGREDIENTQ0MQD1073QATENOLOL AND CHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CHLORTHALIDONEACTIVE INGREDIENTQ0MQD1073QATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.]1
CHLORTHALIDONEACTIVE INGREDIENTQ0MQD1073QATENOLOL AND CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CHLORTHALIDONEACTIVE INGREDIENTQ0MQD1073QATENOLOL AND CHLORTHALIDONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL AND CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL AND CHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL AND CHLORTHALIDONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CHLORTHALIDONEACTIVE MOIETYQ0MQD1073QATENOLOL AND CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CHLORTHALIDONEACTIVE MOIETYQ0MQD1073QATENOLOL AND CHLORTHALIDONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CHLORTHALIDONEACTIVE MOIETYQ0MQD1073QATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.]1
CHLORTHALIDONEACTIVE MOIETYQ0MQD1073QATENOLOL AND CHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL AND CHLORTHALIDONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL AND CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL AND CHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL AND CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL AND CHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL AND CHLORTHALIDONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EATENOLOL AND CHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.]1
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQATENOLOL AND CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQATENOLOL AND CHLORTHALIDONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL AND CHLORTHALIDONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL AND CHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL AND CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5782ATENOLOL AND CHLORTHALIDONE TABLET [ACTAVIS PHARMA, INC.]17Current NDC, Legacy NDC, 1 package rows20250417_a6794dfa-adbb-491b-9d48-f89a44e866c5.zip

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
197382atenolol 100 MG / chlorthalidone 25 MG Oral TabletPSNa6794dfa-adbb-491b-9d48-f89a44e866c517
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletPSNa6794dfa-adbb-491b-9d48-f89a44e866c517
197382atenolol 100 MG / chlorthalidone 25 MG Oral TabletSCDa6794dfa-adbb-491b-9d48-f89a44e866c517
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletSCDa6794dfa-adbb-491b-9d48-f89a44e866c517
197382atenolol 100 MG / chlorthalidone 25 MG Oral TabletPSNcd4f6a14-a2eb-4157-83a7-91ab4e9926e51
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletPSN18a6026b-a790-44b6-bf03-a17a1a7dac7a1
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletPSN73705d59-49fa-4e5d-8e3b-13bc2ac8796b1
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletPSNcd4f6a14-a2eb-4157-83a7-91ab4e9926e51
197382atenolol 100 MG / chlorthalidone 25 MG Oral TabletSCDcd4f6a14-a2eb-4157-83a7-91ab4e9926e51
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletSCD18a6026b-a790-44b6-bf03-a17a1a7dac7a1
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletSCD73705d59-49fa-4e5d-8e3b-13bc2ac8796b1
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletSCDcd4f6a14-a2eb-4157-83a7-91ab4e9926e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-5782-000059157820068970 TABLET in 1 BOX (0591-5782-00)68970 tablet01-AUG-92Current
0591-5782-0100591578201100 TABLET in 1 BOTTLE (0591-5782-01) 100 tablet1992-08-010000-00-00NoNoCurrent
0591-5782-770059157827782764 TABLET in 1 CONTAINER (0591-5782-77)82764 tablet04-JUL-24Current