0049-4900 NDC - ZOLOFT (SERTRALINE HYDROCHLORIDE)

Drug Information

Product NDC: 0049-4900
Proprietary Name: Zoloft
Non Proprietary Name: sertraline hydrochloride
Active Ingredient(s): 50 mg/1 SERTRALINE HYDROCHLORIDE
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Pharmacy Class(es): Cytochrome P450 2D6 Inhibitors [MoA]; Serotonin Reuptake Inhibitor [EPC]; Serotonin Uptake Inhibitors [MoA]

Labeler Information

Field Name	Field Value
Labeler Name:	ROERIG
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	NDA019839
Marketing Category:	NDA
Start Marketing Date:	2/11/1992

Package Information

No.	Package Code	Package Description	Billing Unit
1	0049-4900-30	30 TABLET, FILM COATED in 1 BOTTLE (0049-4900-30)	EA
2	0049-4900-41	100 BLISTER PACK in 1 CARTON (0049-4900-41) / 1 TABLET, FILM COATED in 1 BLISTER PACK	EA
3	0049-4900-66	100 TABLET, FILM COATED in 1 BOTTLE (0049-4900-66)
4	0049-4900-73	500 TABLET, FILM COATED in 1 BOTTLE (0049-4900-73)
5	0049-4900-94	5000 TABLET, FILM COATED in 1 BOTTLE (0049-4900-94)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	0049-4900	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	Zoloft	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	sertraline hydrochloride	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, FILM COATED	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	2/11/1992	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	NDA	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	NDA019839	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	ROERIG	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	SERTRALINE HYDROCHLORIDE	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	50
ACTIVE INGRED UNIT	mg/1
PHARM CLASSES	Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]

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This page was last updated on: 5/26/2025

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