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Marcaine Hcl W/ Epinephrine Drug - Marcaine Hcl W/ Epinephrine The trade name of the product as shown on the labeling. Dosage - INJECTABLE; INJECTION The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Bupivacaine Hydrochloride; Epinephrine Bitartrate Multiple ingredients are in alphabetical order. Strength - 0.25%;0.0091MG/ML The potency of the active ingredient(s), Bupivacaine Hydrochloride; Epinephrine Bitartrate. May repeat for multiple part products. Applicant - HOSPIRA The firm name holding legal responsibility for Marcaine Hcl W/ Epinephrine. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 016964 The FDA assigned number to Marcaine Hcl W/ Epinephrine. Format is nnnnnn. Product Number - 004 The FDA assigned number to identify Marcaine Hcl W/ Epinephrine. Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) Code - AP The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval Date - Approved Prior to Jan 1, 1982 The date Marcaine Hcl W/ Epinephrine 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 Marcaine Hcl W/ Epinephrine. 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 Marcaine Hcl W/ Epinephrine is in. Format is RX, OTC, DISCN. Applicant Full Name - Hospira Inc The full name of the firm holding legal responsibility for the new application of Marcaine Hcl W/ Epinephrine. Marcaine Hcl W/ Epinephrine Sensorcaine 0.75% Injectable; Spinal Bupivacaine Hcl And Epinephrine 0.25%;0.005mg/ml Injectable; Injection Bupivacaine Hcl And Epinephrine 0.25%;0.005mg/ml Injectable; Injection Bupivacaine Hcl And Epinephrine 0.25%;0.005mg/ml Injectable; Injection Bupivacaine Hcl And Epinephrine 0.5%;0.005mg/ml Injectable; Injection Bupivacaine Hcl And Epinephrine 0.5%;0.005mg/ml Injectable; Injection Bupivacaine Hcl And Epinephrine 0.5%;0.005mg/ml Injectable; Injection Bupivacaine Hcl And Epinephrine 0.75%;0.005mg/ml Injectable; Injection Marcaine Hcl W/ Epinephrine 0.25%;0.0091mg/ml Injectable; Injection Marcaine 0.75% Injectable; Spinal NewDrugInformation