Norco

   
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Norco


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

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Acetaminophen; Hydrocodone Bitartrate
Multiple ingredients are in alphabetical order.

Strength - 325MG;5MG
The potency of the active ingredient(s), Acetaminophen; Hydrocodone Bitartrate. May repeat for multiple part products.

Applicant - WATSON LABS
The firm name holding legal responsibility for Norco. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 040099
The FDA assigned number to Norco. Format is nnnnnn.

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

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

Approval Date - Jun 25, 1997
The date Norco 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 Norco. 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 Norco is in. Format is RX, OTC, DISCN.

Applicant Full Name - Watson Laboratories
The full name of the firm holding legal responsibility for the new application of Norco.

Norco