FDA.reportPublic FDA data

Atenolol and Chlorthalidone

Product NDC
21695-743
11-digit product format
216950743
Labeler code
21695
Product ID
21695-743_cd4f6a14-a2eb-4157-83a7-91ab4e9926e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol and Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA073665
Marketing category
ANDA
Marketing start
1992-08-01
Marketing end
0000-00-00
Substance
ATENOLOL; CHLORTHALIDONE
Active strength
50 mg/1; mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Thiazide-like Diuretic [EPC],Increased Diuresis [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-743-302019-09-24C16284748780-1934fe258-4a85-48b1-e053-8cdaa90a720aAtenolol and Chlorthalidone Tablets USP Revised: June 2009 Rx only 190808

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-743-30Atenolol and Chlorthalidone30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-743-30EA - Each21695-743e1143aff-4fb7-40f6-add2-c24d78aaab2f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.]1
CHLORTHALIDONEACTIVE INGREDIENTQ0MQD1073QATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.]1
CHLORTHALIDONEACTIVE MOIETYQ0MQD1073QATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.]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
21695-743ATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20100921_cd4f6a14-a2eb-4157-83a7-91ab4e9926e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197382atenolol 100 MG / chlorthalidone 25 MG Oral TabletPSNcd4f6a14-a2eb-4157-83a7-91ab4e9926e51
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 TabletSCDcd4f6a14-a2eb-4157-83a7-91ab4e9926e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-743-302169507433030 in 1 BOTTLEHistorical