Nadolol

Product NDC
69238-1125
11-digit product format
692381125
Labeler code
69238
Product ID
69238-1125_c1092e52-cd19-48ff-8c50-476c5243667a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nadolol
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA208832
Marketing category
ANDA
Marketing start
2017-06-02
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
69238-1125-1Nadolol1000 in 1 BOTTLETABLET10009
69238-1125-3Nadolol30 in 1 BOTTLETABLET309
69238-1125-9Nadolol90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1125-9EA - Each69238-11252298114a-7860-4b4d-b4e9-6814b9035c1312017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1125NADOLOL TABLET [AMNEAL PHARMACEUTICALS NY LLC]9Current NDC, Legacy NDC, 3 package rows20241011_e2e24b14-0169-4028-828a-894ad3c2ba55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198006nadolol 20 MG Oral TabletPSNe2e24b14-0169-4028-828a-894ad3c2ba559
198007nadolol 40 MG Oral TabletPSNe2e24b14-0169-4028-828a-894ad3c2ba559
198008nadolol 80 MG Oral TabletPSNe2e24b14-0169-4028-828a-894ad3c2ba559
198006nadolol 20 MG Oral TabletSCDe2e24b14-0169-4028-828a-894ad3c2ba559
198007nadolol 40 MG Oral TabletSCDe2e24b14-0169-4028-828a-894ad3c2ba559
198008nadolol 80 MG Oral TabletSCDe2e24b14-0169-4028-828a-894ad3c2ba559

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1125-1692381125011000 TABLET in 1 BOTTLE (69238-1125-1) 1000 tablet2017-06-020000-00-00NoNoCurrent
69238-1125-36923811250330 TABLET in 1 BOTTLE (69238-1125-3) 30 tablet2017-06-020000-00-00NoNoCurrent
69238-1125-96923811250990 TABLET in 1 BOTTLE (69238-1125-9) 90 tablet2017-06-020000-00-00NoNoCurrent