FDA.reportPublic FDA data

Nadolol

Product NDC
68382-734
11-digit product format
683820734
Labeler code
68382
Product ID
68382-734_d91f4594-496e-49f2-a187-ddd86f8634b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nadolol
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA207761
Marketing category
ANDA
Marketing start
2017-08-08
Substance
NADOLOL
Active strength
80 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
8fcb295c-5817-6981-e90d-9999d4e8f347Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-734-01Nadolol100 in 1 BOTTLETABLET1006
68382-734-10Nadolol1000 in 1 BOTTLETABLET10006
68382-734-16Nadolol90 in 1 BOTTLETABLET906
68382-734-30Nadolol1 in 1 BLISTER PACKTABLET16
68382-734-77Nadolol10 in 1 CARTONTABLET106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-734-01EA - Each68382-73491ab2307-f52a-4876-9e88-febb3a4e22c912017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-734NADOLOL TABLET [ZYDUS PHARMACEUTICALS USA INC.]6Current NDC, Legacy NDC, 5 package rows20240109_a0a38f9b-268d-4463-881d-5bee6cd92e8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198008nadolol 80 MG Oral TabletPSN0d66548a-231e-4104-be0c-c6ce1586b46c9
198008nadolol 80 MG Oral TabletSCD0d66548a-231e-4104-be0c-c6ce1586b46c9
198006nadolol 20 MG Oral TabletPSNa0a38f9b-268d-4463-881d-5bee6cd92e8a6
198007nadolol 40 MG Oral TabletPSNa0a38f9b-268d-4463-881d-5bee6cd92e8a6
198008nadolol 80 MG Oral TabletPSNa0a38f9b-268d-4463-881d-5bee6cd92e8a6
198006nadolol 20 MG Oral TabletSCDa0a38f9b-268d-4463-881d-5bee6cd92e8a6
198007nadolol 40 MG Oral TabletSCDa0a38f9b-268d-4463-881d-5bee6cd92e8a6
198008nadolol 80 MG Oral TabletSCDa0a38f9b-268d-4463-881d-5bee6cd92e8a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-734-0168382073401100 TABLET in 1 BOTTLE (68382-734-01) 100 tablet2017-08-080000-00-00NoNoCurrent
68382-734-10683820734101000 TABLET in 1 BOTTLE (68382-734-10) 1000 tablet2017-08-080000-00-00NoNoCurrent
68382-734-166838207341690 TABLET in 1 BOTTLE (68382-734-16) 90 tablet2017-08-080000-00-00NoNoCurrent
68382-734-30683820734301 in 1 BLISTER PACKHistorical
68382-734-776838207347710 BLISTER PACK in 1 CARTON (68382-734-77) / 1 TABLET in 1 BLISTER PACK (68382-734-30) 10 blister pack2017-08-080000-00-00NoNoCurrent