Nadolol

Product NDC
0378-1132
11-digit product format
003781132
Labeler code
0378
Product ID
0378-1132_5921734e-f082-4884-8e93-bce6908c69d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nadolol
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA074172
Marketing category
ANDA
Marketing start
1993-10-31
Marketing end
2023-11-30
Substance
NADOLOL
Active strength
80 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1132-01EA - Each0378-1132d2662511-2233-4c53-ab0d-46e533a74d5812012-07-24
0378-1132-10EA - Each0378-1132c062fff7-a60b-4710-80bb-5941175b784612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NADOLOLACTIVE INGREDIENTFEN504330VNADOLOL TABLET [PHYSICIANS TOTAL CARE, INC.]4
NADOLOLACTIVE MOIETYFEN504330VNADOLOL TABLET [PHYSICIANS TOTAL CARE, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKNADOLOL TABLET [PHYSICIANS TOTAL CARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNADOLOL TABLET [PHYSICIANS TOTAL CARE, INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NADOLOL TABLET [PHYSICIANS TOTAL CARE, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNADOLOL TABLET [PHYSICIANS TOTAL CARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NADOLOL TABLET [PHYSICIANS TOTAL CARE, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNADOLOL TABLET [PHYSICIANS TOTAL CARE, INC.]4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198006nadolol 20 MG Oral TabletPSNd208918b-a356-4924-91d9-9593981fe0a64
198007nadolol 40 MG Oral TabletPSNd208918b-a356-4924-91d9-9593981fe0a64
198008nadolol 80 MG Oral TabletPSNd208918b-a356-4924-91d9-9593981fe0a64
198006nadolol 20 MG Oral TabletSCDd208918b-a356-4924-91d9-9593981fe0a64
198007nadolol 40 MG Oral TabletSCDd208918b-a356-4924-91d9-9593981fe0a64
198008nadolol 80 MG Oral TabletSCDd208918b-a356-4924-91d9-9593981fe0a64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-1132-0100378113201100 TABLET in 1 BOTTLE (0378-1132-01) 100 tablet1993-10-310000-00-00NoNoCurrent
0378-1132-10003781132101000 TABLET in 1 BOTTLE (0378-1132-10) 1000 tablet1993-10-310000-00-00NoNoCurrent