60219-1100 NDC - DOXYCYCLINE HYCLATE (DOXYCYCLINE)

Drug Information

Product NDC: 60219-1100
Proprietary Name: Doxycycline Hyclate
Non Proprietary Name: Doxycycline
Active Ingredient(s): 100 mg/1 DOXYCYCLINE HYCLATE
Administration Route(s): ORAL
Dosage Form(s): CAPSULE
Pharmacy Class(es): Tetracycline-class Drug [EPC]; Tetracyclines [CS]

Labeler Information

Field Name	Field Value
Labeler Name:	Amneal Pharmaceuticals NY LLC
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	ANDA207289
Marketing Category:	ANDA
Start Marketing Date:	6/28/2016

Package Information

No.	Package Code	Package Description	Billing Unit
1	60219-1100-1	100 CAPSULE in 1 BOTTLE (60219-1100-1)
2	60219-1100-3	20 CAPSULE in 1 BOTTLE (60219-1100-3)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	60219-1100	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	Doxycycline Hyclate	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.
NON PROPRIETARY NAME	Doxycycline	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	CAPSULE	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	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.
START MARKETING DATE	6/28/2016	Name of Company corresponding to the labeler code segment of the Product NDC.
MARKETING CATEGORY NAME	ANDA	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.
APPLICATION NUMBER	ANDA207289	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	Amneal Pharmaceuticals NY LLC	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	DOXYCYCLINE HYCLATE	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	100
ACTIVE INGRED UNIT	mg/1
PHARM CLASSES	Tetracycline-class Drug [EPC], Tetracyclines [CS]

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

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