FDA.reportPublic FDA data

Atenolol and Chlorthalidone

Product NDC
70954-390
11-digit product format
709540390
Labeler code
70954
Product ID
70954-390_1dade55e-a8a5-4e38-8ad7-9caa4ceb0cd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol and Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA215560
Marketing category
ANDA
Marketing start
2021-10-25
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
70954-390-10Atenolol and Chlorthalidone100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-390-10EA - Each70954-390c62e2741-5228-40d5-ad08-2aa140c112e512022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-390ATENOLOL AND CHLORTHALIDONE TABLET [ANI PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 1 package rows20240322_33690cc7-fffc-4620-888d-7f6453fe58c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197382atenolol 100 MG / chlorthalidone 25 MG Oral TabletPSN33690cc7-fffc-4620-888d-7f6453fe58c12
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletPSN33690cc7-fffc-4620-888d-7f6453fe58c12
197382atenolol 100 MG / chlorthalidone 25 MG Oral TabletSCD33690cc7-fffc-4620-888d-7f6453fe58c12
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletSCD33690cc7-fffc-4620-888d-7f6453fe58c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-390-1070954039010100 TABLET in 1 BOTTLE (70954-390-10) 100 tablet2021-10-250000-00-00NoNoCurrent