69097-821 NDC - GEMFIBROZIL

Drug Information

Product NDC: 69097-821
Proprietary Name: Gemfibrozil
Non Proprietary Name: Gemfibrozil
Active Ingredient(s): 600 mg/1 GEMFIBROZIL
Administration Route(s): ORAL
Dosage Form(s): TABLET
Pharmacy Class(es): PPAR alpha [CS]; Peroxisome Proliferator Receptor alpha Agonist [EPC]; Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]

Labeler Information

Field Name	Field Value
Labeler Name:	Cipla USA Inc.
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	ANDA077836
Marketing Category:	ANDA
Start Marketing Date:	10/13/2016

Package Information

No.	Package Code	Package Description	Billing Unit
1	69097-821-03	60 TABLET in 1 BOTTLE (69097-821-03)	EA
2	69097-821-07	100 TABLET in 1 BOTTLE (69097-821-07)
3	69097-821-12	500 TABLET in 1 BOTTLE (69097-821-12)	EA

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	69097-821	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PRODUCT TYPE NAME	HUMAN PRESCRIPTION DRUG	This is the date that the labeler indicates was the start of its marketing of the drug product.
PROPRIETARY NAME	Gemfibrozil	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	Gemfibrozil	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	TABLET	Name of Company corresponding to the labeler code segment of the Product NDC.
ROUTE NAME	ORAL	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.
START MARKETING DATE	10/13/2016	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
MARKETING CATEGORY NAME	ANDA	This is the date that the labeler indicates was the start of its marketing of the drug product.
APPLICATION NUMBER	ANDA077836	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	Cipla USA 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	GEMFIBROZIL	Name of Company corresponding to the labeler code segment of the Product NDC.
ACTIVE NUMERATOR STRENGTH	600
ACTIVE INGRED UNIT	mg/1
PHARM CLASSES	PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]	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.

Download Record

Download this NDC record record in Text format: Export

Download this NDC record record in Excel (CSV) format: Export

Download this NDC record record in XML format: Export

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

Previous Code

Next Code