FDA.reportPublic FDA data

Atenolol and Chlorthalidone

Product NDC
16714-937
11-digit product format
167140937
Labeler code
16714
Product ID
16714-937_8ca5026f-56b1-4f46-96f0-a36ace459fb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol and Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Northstar Rx LLC.
Application
ANDA210028
Marketing category
ANDA
Marketing start
2019-03-26
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
8525e779-537f-e5cc-2515-089ecce5f50fProduct name920221128
faf41ef3-b4b3-a29e-3b26-07c3009003bfProduct name520220517
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
5eb1a708-d713-e905-0a08-b103c64796f4Product name320201019
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3f5e2da3-8b99-f714-3261-2c998ee07b05Product name120140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-937-01Atenolol and Chlorthalidone100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-937-01EA - Each16714-9379604163a-1f4a-46f1-ad80-722c546324d212019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-937ATENOLOL AND CHLORTHALIDONE TABLET [NORTHSTAR RX LLC.]3Current NDC, Legacy NDC, 1 package rows20240306_1494d5f7-8620-46da-8bca-69b76cd17635.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197382atenolol 100 MG / chlorthalidone 25 MG Oral TabletPSN1494d5f7-8620-46da-8bca-69b76cd176353
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletPSN1494d5f7-8620-46da-8bca-69b76cd176353
197382atenolol 100 MG / chlorthalidone 25 MG Oral TabletSCD1494d5f7-8620-46da-8bca-69b76cd176353
197383atenolol 50 MG / chlorthalidone 25 MG Oral TabletSCD1494d5f7-8620-46da-8bca-69b76cd176353

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-937-0116714093701100 TABLET in 1 BOTTLE (16714-937-01) 100 tablet2019-03-260000-00-00NoNoCurrent