76420-906 NDC - LUBIPROSTONE (LUBIPROSTONE)

Drug Information

Product NDC: 76420-906
Proprietary Name: Lubiprostone
Non Proprietary Name: lubiprostone
Active Ingredient(s): 8 ug/1 LUBIPROSTONE
Administration Route(s): ORAL
Dosage Form(s): CAPSULE, GELATIN COATED
Pharmacy Class(es): Chloride Channel Activator [EPC]; Chloride Channel Activators [MoA]

Labeler Information

Field Name	Field Value
Labeler Name:	Asclemed USA, Inc.
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	NDA021908
Marketing Category:	NDA AUTHORIZED GENERIC
Start Marketing Date:	1/1/2023

Package Information

No.	Package Code	Package Description	Billing Unit
1	76420-906-01	100 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-01)
2	76420-906-30	30 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-30)
3	76420-906-60	60 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-60)
4	76420-906-90	90 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-90)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	76420-906	Name of Company corresponding to the labeler code segment of the Product 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	Lubiprostone	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.
NON PROPRIETARY NAME	lubiprostone	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.
DOSAGE FORM NAME	CAPSULE, GELATIN COATED	Name of Company corresponding to the labeler code segment of the Product NDC.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	1/1/2023	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 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.
APPLICATION NUMBER	NDA021908	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.
LABELER NAME	Asclemed USA, Inc.	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	LUBIPROSTONE	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	8
ACTIVE INGRED UNIT	ug/1
PHARM CLASSES	Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]

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

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