62332-404 NDC - NADOLOL

Drug Information

Product NDC: 62332-404
Proprietary Name: NADOLOL
Non Proprietary Name: NADOLOL
Active Ingredient(s): 80 mg/1 NADOLOL
Administration Route(s): ORAL
Dosage Form(s): TABLET
Pharmacy Class(es): Adrenergic beta-Antagonists [MoA]; beta-Adrenergic Blocker [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	Alembic Pharmaceuticals Inc.
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	ANDA211763
Marketing Category:	ANDA
Start Marketing Date:	6/8/2023

Package Information

No.	Package Code	Package Description	Billing Unit
1	62332-404-30	30 TABLET in 1 BOTTLE (62332-404-30)
2	62332-404-31	100 TABLET in 1 BOTTLE (62332-404-31)
3	62332-404-91	1000 TABLET in 1 BOTTLE (62332-404-91)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	62332-404	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	HUMAN PRESCRIPTION DRUG	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	NADOLOL	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	NADOLOL	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	TABLET	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE	6/8/2023	A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
MARKETING CATEGORY NAME	ANDA	This is the date that the labeler indicates was the start of its marketing of the drug product.
APPLICATION NUMBER	ANDA211763	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAME	Alembic Pharmaceuticals Inc.	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
SUBSTANCE NAME	NADOLOL	Name of Company corresponding to the labeler code segment of the Product NDC.
ACTIVE NUMERATOR STRENGTH	80
ACTIVE INGRED UNIT	mg/1
PHARM CLASSES	Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]

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This page was last updated on: 11/21/2025

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