FDA.reportPublic FDA data

Nadolol

Product NDC
70771-1089
11-digit product format
707711089
Labeler code
70771
Product ID
70771-1089_af4aa709-b3ff-49c4-91d5-353a99d46696
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nadolol
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA207761
Marketing category
ANDA
Marketing start
2017-08-08
Substance
NADOLOL
Active strength
20 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
NADOLOL20 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
70771-1089-0Nadolol1000 in 1 BOTTLETABLET10007
70771-1089-1Nadolol100 in 1 BOTTLETABLET1007
70771-1089-2Nadolol1 in 1 BLISTER PACKTABLET17
70771-1089-4Nadolol10 in 1 CARTONTABLET107
70771-1089-9Nadolol90 in 1 BOTTLETABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1089NADOLOL TABLET [ZYDUS LIFESCIENCES LIMITED]7Current NDC, Legacy NDC, 5 package rows20241207_29433c5a-51c6-4fb9-9174-1b1c616c9e57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198006nadolol 20 MG Oral TabletPSN29433c5a-51c6-4fb9-9174-1b1c616c9e577
198007nadolol 40 MG Oral TabletPSN29433c5a-51c6-4fb9-9174-1b1c616c9e577
198008nadolol 80 MG Oral TabletPSN29433c5a-51c6-4fb9-9174-1b1c616c9e577
198006nadolol 20 MG Oral TabletSCD29433c5a-51c6-4fb9-9174-1b1c616c9e577
198007nadolol 40 MG Oral TabletSCD29433c5a-51c6-4fb9-9174-1b1c616c9e577
198008nadolol 80 MG Oral TabletSCD29433c5a-51c6-4fb9-9174-1b1c616c9e577

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1089-0707711089001000 TABLET in 1 BOTTLE (70771-1089-0) 1000 tablet2017-08-080000-00-00NoNoCurrent
70771-1089-170771108901100 TABLET in 1 BOTTLE (70771-1089-1) 100 tablet2017-08-080000-00-00NoNoCurrent
70771-1089-2707711089021 in 1 BLISTER PACKHistorical
70771-1089-47077110890410 BLISTER PACK in 1 CARTON (70771-1089-4) / 1 TABLET in 1 BLISTER PACK (70771-1089-2) 10 blister pack2017-08-080000-00-00NoNoCurrent
70771-1089-97077110890990 TABLET in 1 BOTTLE (70771-1089-9) 90 tablet2017-08-080000-00-00NoNoCurrent