FDA.reportPublic FDA data

Atenolol and Chlorthalidone

Product NDC
29300-401
11-digit product format
293000401
Labeler code
29300
Product ID
29300-401_383b2bb2-513e-4bcf-8fc7-32c0cda3481e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol and Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA213302
Marketing category
ANDA
Marketing start
2020-11-25
Substance
ATENOLOL; CHLORTHALIDONE
Active strength
100; 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
ATENOLOL100 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
29300-401-01Atenolol and Chlorthalidone100 in 1 BOTTLETABLET1005
29300-401-05Atenolol and Chlorthalidone500 in 1 BOTTLETABLET5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-401-01EA - Each29300-401b284f741-7f30-48a8-8c97-fbbd3d6dd12a12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-401ATENOLOL AND CHLORTHALIDONE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]5Current NDC, Legacy NDC, 2 package rows20240123_a85d28c1-e812-4c12-aa67-136bff3610e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197382atenolol 100 MG / chlorthalidone 25 MG Oral TabletPSNa85d28c1-e812-4c12-aa67-136bff3610e55
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletPSNa85d28c1-e812-4c12-aa67-136bff3610e55
197382atenolol 100 MG / chlorthalidone 25 MG Oral TabletSCDa85d28c1-e812-4c12-aa67-136bff3610e55
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletSCDa85d28c1-e812-4c12-aa67-136bff3610e55
197382atenolol 100 MG / chlorthalidone 25 MG Oral TabletPSNdfbd0160-f56a-41b9-a4ff-eb2df73b1e9b2
197382atenolol 100 MG / chlorthalidone 25 MG Oral TabletSCDdfbd0160-f56a-41b9-a4ff-eb2df73b1e9b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-401-0129300040101100 TABLET in 1 BOTTLE (29300-401-01) 100 tablet2020-12-140000-00-00NoNoCurrent
29300-401-0529300040105500 TABLET in 1 BOTTLE (29300-401-05) 500 tablet2020-12-140000-00-00NoNoCurrent