FDA.reportPublic FDA data

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

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
Unii50VV3VW0TI, Q0MQD1073Q
Rxcui197383

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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

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

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