69238-1831 NDC - LEVOTHYROXINE SODIUM

Drug Information

Product NDC: 69238-1831
Proprietary Name: Levothyroxine Sodium
Non Proprietary Name: Levothyroxine Sodium
Active Ingredient(s): .05 mg/1 LEVOTHYROXINE SODIUM
Administration Route(s): ORAL
Dosage Form(s): TABLET
Pharmacy Class(es): Thyroxine [CS]; l-Thyroxine [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	Amneal Pharmaceuticals NY LLC
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	NDA021210
Marketing Category:	NDA AUTHORIZED GENERIC
Start Marketing Date:	12/1/2003

Package Information

No.	Package Code	Package Description	Billing Unit
1	69238-1831-1	100 TABLET in 1 BOTTLE, PLASTIC (69238-1831-1)	EA
2	69238-1831-7	1000 TABLET in 1 BOTTLE, PLASTIC (69238-1831-7)	EA

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	69238-1831	The translation of the route code submitted by the firm, indicating route of administration.
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	Levothyroxine Sodium	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	Levothyroxine Sodium	Name of Company corresponding to the labeler code segment of the Product NDC.
DOSAGE FORM NAME	TABLET	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	12/1/2003	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	NDA AUTHORIZED GENERIC
APPLICATION NUMBER	NDA021210	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	LEVOTHYROXINE SODIUM	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	.05
ACTIVE INGRED UNIT	mg/1
PHARM CLASSES	Thyroxine [CS], l-Thyroxine [EPC]

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

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