BUPIVACAINE HYDROCHLORIDE injection, solution
BUPIVACAINE HYDROCHLORIDE injection, solution is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including BUPIVACAINE HYDROCHLORIDE injection, solution. Available dosage form: injection, solution.
Drug Details
- Generic Name
- BUPIVACAINE HYDROCHLORIDE injection, solution
- Brand Names
- BUPIVACAINE HYDROCHLORIDE injection, solution
- Application Number
- ANDA207183
- Sponsor
- HF Acquisition Co LLC, DBA HealthFirst
- NDC Codes
- 1
- Dosage Forms
- INJECTION, SOLUTION
- Routes
- PERINEURAL
- Active Ingredients
- BUPIVACAINE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see DOSAGE AND ADMINISTRATION ]. Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [see DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , WARNINGS AND PRECAUTIONS ].