Approved Drug Products with Therapeutic Equivalence Products

$716 / year

This dataset is also called Orange Book. The dataset contains drug ingredient, dosage form, route, trade name, strength, product number, therapeutic equivalence code etc. for approved drug products with therapeutic equivalence.


The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act).
The Approved Drug Products list first appeared as a print publication in October 1980. With the 25th edition (2005), Portable Document Format (PDF) versions of the Annual Edition and the Cumulative Supplement became available.
The Orange Book Search was added to the FDA website October 31, 1997.

Date Created


Last Modified




Update Frequency


Temporal Coverage

1981 to 2019-05

Spatial Coverage

United States


John Snow Labs; U.S. Food and Drug Administration;

Source License URL

Source License Requirements


Source Citation



Approved Drug, Therapeutic Equivalence, Drug Exclusivity, Drug Book, Orange Book, Generic Drug Products, Drugs List, FDA Approved Drug Products

Other Titles

Newly Approved Drug with Therapeutic Equivalence, Product Number of Approved Drug Product, Trade Names of Drugs with Therapeutic Equivalence, Approved with Therapeutic Equivalence Evaluations Book FDA Drug Products, Approved with Therapeutic Equivalence Evaluations Drug Book Products, Approved Generic Drug Products with Therapeutic Equivalence

IngredientThe active ingredient(s) for the product. Multiple ingredients are in alphabetical order, separated by a comma.stringrequired : 1
Dosage_Form_RouteThe product dosage form and route separated by a comma.stringrequired : 1
Trade_NameThe trade name of the product as shown on the labeling.stringrequired : 1
ApplicantThe firm name holding legal responsibility for the new drug application. The firm name is condensed to a maximum twenty character unique string.stringrequired : 1
StrengthThe potency of the active ingredient. May repeat for multiple part products.string-
Application_TypeThe type of new drug application approval. New Drug Applications (NDA or innovator) or Abbreviated New Drug Applications (ANDA or generic).stringrequired : 1
Application_NoNew Drug Application (NDA) Number. The FDA assigned number to the application.numberrequired : 1 level : Nominal
Product_NoThe FDA assigned number to identify the application products. Each strength is a separate product. May repeat for multiple part products.numberrequired : 1 level : Nominal
Therapeutic_Equivalence_CodeTherapeutic Equivalence (TE) Code. The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx productsstring-
Approval_DateThe date the product was approved as stated in the FDA approval letter to the applicant. The format is yyyy-mm-dd. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".daterequired : 1
Is_Reference_Listed_Drugsbooleanrequired : 1
TypeThe group or category of approved drugs. Format is RX, OTC, DISCN.stringrequired : 1
Applicant_Full_NameThe full name of the firm holding legal responsibility for the new drug application.stringrequired : 1
PIMOZIDETABLET;ORALORAPTEVA1MGNew Drug Applications (NDA or innovator)174733AB1997-08-27trueNoRX
PIMOZIDETABLET;ORALORAPTEVA2MGNew Drug Applications (NDA or innovator)174731AB1984-07-31trueYesRX
DIAZEPAMTABLET;ORALVALIUMROCHE2MGNew Drug Applications (NDA or innovator)132632AB1982-01-01trueNoRX
DIAZEPAMTABLET;ORALVALIUMROCHE5MGNew Drug Applications (NDA or innovator)132634AB1982-01-01trueNoRX
TADALAFILTABLET;ORALCIALISLILLY5MGNew Drug Applications (NDA or innovator)213681AB2003-11-21trueNoRX
IBUPROFENTABLET;ORALIBUBASF400MGNew Drug Applications (NDA or innovator)1819711982-01-01falseNoDISCN
ZALEPLONCAPSULE;ORALSONATAPFIZER5MGNew Drug Applications (NDA or innovator)208591AB1999-08-13trueNoRX
DAPSONEGEL;TOPICALACZONEALLERGAN5%New Drug Applications (NDA or innovator)217941AB2005-07-07trueYesRX
LORAZEPAMTABLET;ORALATIVANBAUSCH1MGNew Drug Applications (NDA or innovator)177942AB1982-01-01trueNoRX
TADALAFILTABLET;ORALCIALISLILLY10MGNew Drug Applications (NDA or innovator)213682AB2003-11-21trueNoRX