FDA.reportPublic FDA data

NADOLOL

Product NDC
71335-3127
11-digit product format
713353127
Labeler code
71335
Product ID
71335-3127_23fb6667-2ab5-4af3-a7a3-210e8a914144
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NADOLOL
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211763
Marketing category
ANDA
Marketing start
2023-06-08
Substance
NADOLOL
Active strength
80 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NADOLOL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NADOLOL80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFEN504330V
Rxcui198008

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
71335-3127-1NADOLOL30 in 1 BOTTLETABLET301
71335-3127-2NADOLOL28 in 1 BOTTLETABLET281
71335-3127-3NADOLOL90 in 1 BOTTLETABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198008nadolol 80 MG Oral TabletPSN64a788d0-b7f0-4f39-8adb-ab68870ecfa51
198008nadolol 80 MG Oral TabletSCD64a788d0-b7f0-4f39-8adb-ab68870ecfa51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3127-17133531270130 TABLET in 1 BOTTLE (71335-3127-1) 30 tablet2026-04-29NoNoHistorical
71335-3127-27133531270228 TABLET in 1 BOTTLE (71335-3127-2) 28 tablet2026-04-29NoNoHistorical
71335-3127-37133531270390 TABLET in 1 BOTTLE (71335-3127-3) 90 tablet2026-04-29NoNoHistorical