Drug - Prepidil
The trade name of the product as shown on the labeling.

The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Dinoprostone
Multiple ingredients are in alphabetical order.

Strength - 0.5MG/3GM
The potency of the active ingredient(s), Dinoprostone. May repeat for multiple part products.

The firm name holding legal responsibility for Prepidil. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019617
The FDA assigned number to Prepidil. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Prepidil. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Dec 9, 1992
The date Prepidil was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - Yes
The pioneer or innovator of Prepidil. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Prepidil is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pharmacia And Upjohn Co
The full name of the firm holding legal responsibility for the new application of Prepidil.