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Last Updated: March 30, 2023

Details for New Drug Application (NDA): 018692

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NDA 018692 describes MARCAINE, which is a drug marketed by Hospira and is included in two NDAs. It is available from one supplier. Additional details are available on the MARCAINE profile page.

The generic ingredient in MARCAINE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.
Summary for 018692
Ingredient:bupivacaine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 018692
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 018692
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MARCAINE bupivacaine hydrochloride INJECTABLE;SPINAL 018692 NDA Hospira, Inc. 0409-1761 0409-1761-02 10 DOSE PACK in 1 CARTON (0409-1761-02) / 1 AMPULE in 1 DOSE PACK / 2 mL in 1 AMPULE (0409-1761-19)
MARCAINE bupivacaine hydrochloride INJECTABLE;SPINAL 018692 NDA Hospira, Inc. 0409-1761 0409-1761-10 2 CELLO PACK in 1 CARTON (0409-1761-10) / 5 AMPULE in 1 CELLO PACK (0409-1761-05) / 2 mL in 1 AMPULE (0409-1761-18)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SPINALStrength0.75%
Approval Date:May 4, 1984TE:APRLD:Yes

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