FDA.reportPublic FDA data

Atenolol and Chlorthalidone

Product NDC
70771-1372
11-digit product format
707711372
Labeler code
70771
Product ID
70771-1372_17b72467-567f-45d7-9e05-86e5f2847f46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol and Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA210028
Marketing category
ANDA
Marketing start
2019-03-12
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
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
70771-1372-1Atenolol and Chlorthalidone100 in 1 BOTTLETABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1372ATENOLOL AND CHLORTHALIDONE TABLET [ZYDUS LIFESCIENCES LIMITED]4Current NDC, Legacy NDC, 1 package rows20241127_a16d6010-a67d-4081-b2a3-ecef9f0f09ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197382atenolol 100 MG / chlorthalidone 25 MG Oral TabletPSNa16d6010-a67d-4081-b2a3-ecef9f0f09ea4
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletPSNa16d6010-a67d-4081-b2a3-ecef9f0f09ea4
197382atenolol 100 MG / chlorthalidone 25 MG Oral TabletSCDa16d6010-a67d-4081-b2a3-ecef9f0f09ea4
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletSCDa16d6010-a67d-4081-b2a3-ecef9f0f09ea4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1372-170771137201100 TABLET in 1 BOTTLE (70771-1372-1) 100 tablet2019-03-120000-00-00NoNoCurrent