FDA.reportPublic FDA data

Nadolol

Product NDC
69097-869
11-digit product format
690970869
Labeler code
69097
Product ID
69097-869_39a5df9f-6bc8-480f-84a6-d051d2cef465
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nadolol
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA203455
Marketing category
ANDA
Marketing start
2016-02-23
Substance
NADOLOL
Active strength
80 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], 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
Nadolol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NADOLOL80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFEN504330V
Rxcui198006, 198007, 198008

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c3e14ce3-3dd7-c88b-aff9-2af221ac8a37Product name920240606
8fcb295c-5817-6981-e90d-9999d4e8f347Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-869-02Nadolol30 in 1 BOTTLETABLET304
69097-869-07Nadolol100 in 1 BOTTLETABLET1004
69097-869-15Nadolol1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-869-07EA - Each69097-8698e87e97a-ad3f-4450-a00e-0b6f1e94535d12016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-869NADOLOL TABLET [CIPLA USA INC.]4Current NDC, Legacy NDC, 3 package rows20240330_c899eedb-4113-45da-acc3-8e181250a7d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198006nadolol 20 MG Oral TabletPSNc899eedb-4113-45da-acc3-8e181250a7d84
198007nadolol 40 MG Oral TabletPSNc899eedb-4113-45da-acc3-8e181250a7d84
198008nadolol 80 MG Oral TabletPSNc899eedb-4113-45da-acc3-8e181250a7d84
198006nadolol 20 MG Oral TabletSCDc899eedb-4113-45da-acc3-8e181250a7d84
198007nadolol 40 MG Oral TabletSCDc899eedb-4113-45da-acc3-8e181250a7d84
198008nadolol 80 MG Oral TabletSCDc899eedb-4113-45da-acc3-8e181250a7d84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-869-026909708690230 TABLET in 1 BOTTLE (69097-869-02) 30 tablet2016-02-230000-00-00NoNoCurrent
69097-869-0769097086907100 TABLET in 1 BOTTLE (69097-869-07) 100 tablet2016-02-230000-00-00NoNoCurrent
69097-869-15690970869151000 TABLET in 1 BOTTLE (69097-869-15) 1000 tablet2016-02-230000-00-00NoNoCurrent