63187-900 NDC - ISOSORBIDE MONONITRATE

Drug Information

Product NDC: 63187-900
Proprietary Name: isosorbide mononitrate
Non Proprietary Name: isosorbide mononitrate
Active Ingredient(s): 20 mg/1 ISOSORBIDE MONONITRATE
Administration Route(s): ORAL
Dosage Form(s): TABLET
Pharmacy Class(es): Nitrate Vasodilator [EPC]; Nitrates [CS]; Vasodilation [PE]

Labeler Information

Field Name	Field Value
Labeler Name:	Proficient Rx LP
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	NDA020215
Marketing Category:	NDA AUTHORIZED GENERIC
Start Marketing Date:	6/30/1993

Package Information

No.	Package Code	Package Description	Billing Unit
1	63187-900-30	30 TABLET in 1 BOTTLE (63187-900-30)	EA
2	63187-900-60	60 TABLET in 1 BOTTLE (63187-900-60)
3	63187-900-90	90 TABLET in 1 BOTTLE (63187-900-90)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	63187-900
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	isosorbide mononitrate	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	isosorbide mononitrate	This is the date that the labeler indicates was the start of its marketing of the drug product.
DOSAGE FORM NAME	TABLET	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	6/30/1993	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	NDA AUTHORIZED GENERIC	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
APPLICATION NUMBER	NDA020215	This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAME	Proficient Rx LP	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.
SUBSTANCE NAME	ISOSORBIDE MONONITRATE	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.
ACTIVE NUMERATOR STRENGTH	20
ACTIVE INGRED UNIT	mg/1
PHARM CLASSES	Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]

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This page was last updated on: 12/6/2025

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